K832059 is an FDA 510(k) clearance for the IONOPHORELIC SWEAT STIM. CHLORIDE-. This device is classified as a Device, Iontophoresis, Specific Uses (Class II - Special Controls, product code KTB).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on August 24, 1983, 58 days after receiving the submission on June 27, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K832059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 1983 |
| Decision Date | August 24, 1983 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KTB — Device, Iontophoresis, Specific Uses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5525 |