The following data is part of a premarket notification filed by Keeler Limited with the FDA for Keeler Slit Lamp H-series Digital (halogen Bulb Option), Keeler Slit Lamp H-series Digital (led Option).
| Device ID | K140451 |
| 510k Number | K140451 |
| Device Name: | KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | KEELER LIMITED 456 PARKWAY Broomall, PA 19008 |
| Contact | Eugene Van Arsdale |
| Correspondent | Eugene Van Arsdale KEELER LIMITED 456 PARKWAY Broomall, PA 19008 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-24 |
| Decision Date | 2014-07-11 |
| Summary: | summary |