K913601 is an FDA 510(k) clearance for the MICROPHOR. This device is classified as a Device, Iontophoresis, Other Uses (Class II - Special Controls, product code EGJ).
Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on July 15, 1994, 1067 days after receiving the submission on August 13, 1991.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K913601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1991 |
| Decision Date | July 15, 1994 |
| Days to Decision | 1067 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | EGJ — Device, Iontophoresis, Other Uses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5525 |