The following data is part of a premarket notification filed by Appasamy Associates with the FDA for Aaio-7, Aaio Wirless.
| Device ID | K110205 |
| 510k Number | K110205 |
| Device Name: | AAIO-7, AAIO WIRLESS |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | APPASAMY ASSOCIATES 20, SBI OFFICERS COLONY 1ST STREET Arumbakkam, Chennai, IN 600 106 |
| Contact | K Rengasamy |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-01-25 |
| Decision Date | 2011-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869228000434 | K110205 | 000 |