The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Vantage Indirect Ophthalmoscope.
| Device ID | K060822 |
| 510k Number | K060822 |
| Device Name: | VANTAGE INDIRECT OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Eugene R Vanarsdale |
| Correspondent | Eugene R Vanarsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-27 |
| Decision Date | 2006-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272718233 | K060822 | 000 |
| 05055272711319 | K060822 | 000 |
| 05055272711272 | K060822 | 000 |
| 05055272711241 | K060822 | 000 |
| 05055272702782 | K060822 | 000 |
| 05055272702669 | K060822 | 000 |
| 05055272702621 | K060822 | 000 |