K905237 is an FDA 510(k) clearance for the EYE SEE INSTRUMENT. This device is classified as a Magnet, Permanent (Class I - General Controls, product code HPN).
Submitted by King Tool, Inc. (Bozeman, US). The FDA issued a Cleared decision on February 14, 1991, 90 days after receiving the submission on November 16, 1990.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4445.
| 510(k) Number | K905237 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 1990 |
| Decision Date | February 14, 1991 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPN — Magnet, Permanent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4445 |