K771130 is an FDA 510(k) clearance for the DESENSITRON. This device is classified as a Device, Iontophoresis, Other Uses (Class II - Special Controls, product code EGJ).
Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 15, 1977, 22 days after receiving the submission on June 23, 1977.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K771130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1977 |
| Decision Date | July 15, 1977 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | EGJ — Device, Iontophoresis, Other Uses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5525 |