K894513 is an FDA 510(k) clearance for the DIATHRON(R) DIATHERMY UNIT. This device is classified as a Transilluminator, Ac-powered (Class II - Special Controls, product code HJM).
Submitted by Intl. Ophthalmic Industries Corp. (Weston, US). The FDA issued a Cleared decision on October 31, 1989, 104 days after receiving the submission on July 19, 1989.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1945.
| 510(k) Number | K894513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1989 |
| Decision Date | October 31, 1989 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HJM — Transilluminator, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1945 |