The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Vista Ophthalmoscope (battery And Ac-powered).
| Device ID | K893172 |
| 510k Number | K893172 |
| Device Name: | VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Van Arsdale |
| Correspondent | Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1989-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272700900 | K893172 | 000 |
| 05055272700894 | K893172 | 000 |
| 05055272700788 | K893172 | 000 |
| 05055272700771 | K893172 | 000 |
| 05055272700764 | K893172 | 000 |
| 05055272700641 | K893172 | 000 |
| 05055272719933 | K893172 | 000 |
| 05055272719926 | K893172 | 000 |