K001410 is an FDA 510(k) clearance for the PHORESOR MODEL PM2000. This device is classified as a Device, Iontophoresis, Specific Uses (Class II - Special Controls, product code KTB).
Submitted by Iomed, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 1, 2000, 89 days after receiving the submission on May 4, 2000.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K001410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2000 |
| Decision Date | August 01, 2000 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | KTB — Device, Iontophoresis, Specific Uses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5525 |