K080375 is an FDA 510(k) clearance for the RMX PHYSIOLOGICAL DATA RECORDER. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by S.L.P. , Ltd. (Tel-Aviv, IL). The FDA issued a Cleared decision on September 2, 2008, 203 days after receiving the submission on February 12, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K080375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2008 |
| Decision Date | September 02, 2008 |
| Days to Decision | 203 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 |