K061996 is an FDA 510(k) clearance for the SANDMAN POCKET. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Eb Neuro S.P.A. (Carmel, US). The FDA issued a Cleared decision on October 3, 2006, 81 days after receiving the submission on July 14, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K061996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2006 |
| Decision Date | October 03, 2006 |
| Days to Decision | 81 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 |