K043373 is an FDA 510(k) clearance for the DOLOTENS DENTAL TM 1. This device is classified as a Device, Muscle Monitoring (Class II - Special Controls, product code KZM).
Submitted by Neuromuscular Technologies, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on September 2, 2005, 268 days after receiving the submission on December 8, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 890.1375.
| 510(k) Number | K043373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2004 |
| Decision Date | September 02, 2005 |
| Days to Decision | 268 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KZM — Device, Muscle Monitoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1375 |