510(k) K110064
K110064 is an FDA 510(k) premarket notification submitted by Snap Diagnostics, LLC for the device "SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on March 18, 2011. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Snap Diagnostics, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2011
- Date Received
- January 10, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilatory Effort Recorder
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type