K851034 is an FDA 510(k) clearance for the NOVATHERM. This device is classified as a System, Thermographic, Liquid Crystal, Powered (adjunctive Use) (Class III - Premarket Approval, product code KXZ).
Submitted by Medtech Products, Inc. (Washington, US). The FDA issued a Cleared decision on September 27, 1985, 198 days after receiving the submission on March 13, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2982.
| 510(k) Number | K851034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 1985 |
| Decision Date | September 27, 1985 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | KXZ - System, Thermographic, Liquid Crystal, Powered (adjunctive Use) |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 884.2982 |