The following data is part of a premarket notification filed by Keeler Limited with the FDA for Keeler Slit Lamp.
| Device ID | K151394 |
| 510k Number | K151394 |
| Device Name: | Keeler Slit Lamp |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | KEELER LIMITED CLEWER HILL ROAD Windsor, GB Sl4 4aa |
| Contact | Irina Proutski |
| Correspondent | Irina Proutski Keeler Limited Clewer Hill Road Windsor, GB Sl4 4aa |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-26 |
| Decision Date | 2015-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272715584 | K151394 | 000 |
| 05055272715393 | K151394 | 000 |
| 05055272715386 | K151394 | 000 |
| 05055272715379 | K151394 | 000 |
| 05055272715362 | K151394 | 000 |
| 05055272715355 | K151394 | 000 |
| 05055272715348 | K151394 | 000 |
| 05055272715331 | K151394 | 000 |
| 05055272715324 | K151394 | 000 |
| 05055272715317 | K151394 | 000 |
| 05055272715300 | K151394 | 000 |
| 05055272715294 | K151394 | 000 |
| 05055272715287 | K151394 | 000 |
| 05055272715270 | K151394 | 000 |
| 05055272715263 | K151394 | 000 |
| 05055272715256 | K151394 | 000 |
| 05055272715249 | K151394 | 000 |
| 05055272715409 | K151394 | 000 |
| 05055272715416 | K151394 | 000 |
| 05055272715577 | K151394 | 000 |
| 05055272715560 | K151394 | 000 |
| 05055272715553 | K151394 | 000 |
| 05055272715546 | K151394 | 000 |
| 05055272715539 | K151394 | 000 |
| 05055272715522 | K151394 | 000 |
| 05055272715515 | K151394 | 000 |
| 05055272715508 | K151394 | 000 |
| 05055272715492 | K151394 | 000 |
| 05055272715485 | K151394 | 000 |
| 05055272715478 | K151394 | 000 |
| 05055272715461 | K151394 | 000 |
| 05055272715454 | K151394 | 000 |
| 05055272715447 | K151394 | 000 |
| 05055272715430 | K151394 | 000 |
| 05055272715423 | K151394 | 000 |
| 05055272715232 | K151394 | 000 |