K974855 is an FDA 510(k) clearance for the PHORESOR II, MODEL PM900. 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 March 27, 1998, 88 days after receiving the submission on December 29, 1997.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K974855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | December 29, 1997 |
| Decision Date | March 27, 1998 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | KTB — Device, Iontophoresis, Specific Uses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5525 |