K021176 is an FDA 510(k) clearance for the COMPUMEDICS SOMTE SYSTEM. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Compumedics Limited (Minneapolis,, US). The FDA issued a Cleared decision on January 21, 2003, 284 days after receiving the submission on April 12, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K021176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2002 |
| Decision Date | January 21, 2003 |
| Days to Decision | 284 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNR - Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |