K940373 is an FDA 510(k) clearance for the OPHTHALMIC CRYO UNIT. This device is classified as a Unit, Cryophthalmic (Class II - Special Controls, product code HPS).
Submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on July 18, 1994, 173 days after receiving the submission on January 26, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4170.
| 510(k) Number | K940373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1994 |
| Decision Date | July 18, 1994 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HPS — Unit, Cryophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4170 |