The following data is part of a premarket notification filed by Keller Instruments, Inc. with the FDA for Acu220 Cryo Unit.
| Device ID | K841294 |
| 510k Number | K841294 |
| Device Name: | ACU220 CRYO UNIT |
| Classification | Unit, Cryotherapy, Ophthalmic |
| Applicant | KELLER INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQA |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-29 |
| Decision Date | 1984-08-15 |