The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Vista Streak Retinoscope (ac-powered).
| Device ID | K893171 |
| 510k Number | K893171 |
| Device Name: | VISTA STREAK RETINOSCOPE (AC-POWERED) |
| Classification | Retinoscope, 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 | HKL |
| CFR Regulation Number | 886.1780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1989-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272712873 | K893171 | 000 |
| 05055272719957 | K893171 | 000 |
| 05055272719988 | K893171 | 000 |
| 05055272719995 | K893171 | 000 |
| 05055272701563 | K893171 | 000 |
| 05055272701570 | K893171 | 000 |
| 05055272701587 | K893171 | 000 |
| 05055272701594 | K893171 | 000 |
| 05055272701600 | K893171 | 000 |
| 05055272701662 | K893171 | 000 |
| 05055272719940 | K893171 | 000 |