K895775 is an FDA 510(k) clearance for the CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM. This device is classified as a Device, Iontophoresis, Specific Uses (Class II - Special Controls, product code KTB).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on April 23, 1990, 208 days after receiving the submission on September 27, 1989.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K895775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1989 |
| Decision Date | April 23, 1990 |
| Days to Decision | 208 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 |