Miis Horus Digital Diagnostic Set DSC 100 w/ DGC 100 Speculum & DOC 100S Otoscop

Description

Miis Horus Digital Diagnostic Set DSC 100 w/ DGC 100 Speculum & DOC 100S Otoscope
Spec description
This innovative product “Digital Hand-held diagnostic set” is Class-II (ophthalmoscope)/Class-I (otoscope and dermoscope) Medical Device.
It is expected to substitute for the traditional ophthalmoscope, otoscope and dermoscope by the use of the digital photographic solution. This medical device is provided to capture the digital photograph or video of eye-fundus, ear canal and tympanic membrane, epidermis and dermis of skin. Following the global trend of electronic medical records and telehealthcare networks, this people-oriented medical imaging product will be widely applied in doctors’ offices, clinics, skilled nursing facilities and healthcare station.
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Payment must be received within 4 days of the date of purchase. Otherwise, if no contact has been established, the listing will be void and non-paying bidder (NPB) reported to eBay.
Shipping:
All packages will be shipped within 48 hours after the payment is cleared via FedEx or DHL Expedited / International Shipping with tracking.
Any merchandise sent to another country may be subject to duty under the customs regulations of that country. We do not maintain or provide information concerning the assessment of customs duty. Custom duties, carrier customs clearance brokerage fees and import taxes may apply to international buyers and are not included in shipping and handling charges you pay to us and will be borne by the buyer.
Returns:
We accept returns only if the item was not as described in our listing or found defective on arrival.
Buyer must return the item exactly as received within 14 days and will be responsible for the Return Charges.
Return shipping and handling is sole responsibility of the buyer.
Packaging:
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Device Classification Name
Camera, Ophthalmic, Ac-Powered
510(K) Number
K120982
Device Name
DIGITAL EYE-FUNDUS CAMERA
Applicant
MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS)
1F, NO. 7, R&D RD II
HSUNCHU SCIENCE PARK
Hsinchu,  CN 30076
Applicant Contact
Chih-Lu Hsu
Correspondent
MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS)
1F, NO. 7, R&D RD II
HSUNCHU SCIENCE PARK
Hsinchu,  CN 30076
Correspondent Contact
Chih-Lu Hsu
Regulation Number
886.1120
Classification Product Code
HKI
Date Received
04/02/2012
Decision Date
09/28/2012
Decision
Substantially Equivalent (SESE)
Regulation Medical Specialty
Ophthalmic
510k Review Panel
Ophthalmic
Summary
Summary
Type
Traditional
Reviewed By Third Party
No
Combination Product
No
DISCLAIMER
: Regardless of the origin of the equipment, documentation provided or identification appearing upon the equipment, the equipment described and offered here is in no way certified for, recommended for, or offered for any specific use. The purchaser agrees that the seller shall not be held responsible or liable for any injuries or damages, whether incidental or consequential, associated in any way with the equipment. The purchaser, by bidding on this equipment, indicates their acknowledgment of, and agreement to the terms of this disclaimer.
FDA Usage Statement The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation.
If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA's Center for Devices and Radiological Health:  https://www.fda.gov/cdrh/devadvice https://www.fda.gov/cdrh/industry/support/index Phone number:[phone removed by eBay] email: [email removed by eBay] Thank you for your cooperation.