The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Modified Clinical Widefield Specular Microscope 50.
| Device ID | K854440 |
| 510k Number | K854440 |
| Device Name: | MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 |
| Classification | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
| 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 | HRM |
| CFR Regulation Number | 878.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-05 |
| Decision Date | 1985-12-16 |