K022097 is an FDA 510(k) clearance for the THERMIQUE. This device is classified as a Tester, Pulp (Class II - Special Controls, product code EAT).
Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on September 6, 2002, 71 days after receiving the submission on June 27, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1720.
| 510(k) Number | K022097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2002 |
| Decision Date | September 06, 2002 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EAT — Tester, Pulp |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1720 |