510(k) K151107
K151107 is an FDA 510(k) premarket notification submitted by Capnia, Inc. for the device "CoSense ETCO Monitor". The FDA issued a decision of Substantially Equivalent on July 22, 2015. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430. Capnia, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2015
- Date Received
- April 27, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1430
- Review Panel
- AN
- Submission Type