K110064 is an FDA 510(k) clearance for the SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Snap Diagnostics, LLC (Wheeling, US). The FDA issued a Cleared decision on March 18, 2011, 67 days after receiving the submission on January 10, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K110064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2011 |
| Decision Date | March 18, 2011 |
| Days to Decision | 67 days |
| Submission Type | Special |
| 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 |