K062523 is an FDA 510(k) clearance for the TRU-MR LARYNGOSCOPE SET. This device is classified as a Laryngoscope, Rigid (Class I - General Controls, product code CCW).
Submitted by Truphatek International, Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on November 17, 2006, 81 days after receiving the submission on August 28, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5540.
| 510(k) Number | K062523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2006 |
| Decision Date | November 17, 2006 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCW — Laryngoscope, Rigid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5540 |