The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Keeler Acu 22xt Ophthalmic Cryo Unit.
| Device ID | K874555 |
| 510k Number | K874555 |
| Device Name: | KEELER ACU 22XT OPHTHALMIC CRYO UNIT |
| Classification | Unit, Cryophthalmic |
| 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 | HPS |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-04 |
| Decision Date | 1988-01-29 |