The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Keeler Vantage Indirect Ophthalmoscope.
| Device ID | K942104 |
| 510k Number | K942104 |
| Device Name: | KEELER VANTAGE INDIRECT OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Eugene R Van Arsdale |
| Correspondent | Eugene R 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 | 1994-05-02 |
| Decision Date | 1994-08-04 |