510(k) K130036
K130036 is an FDA 510(k) premarket notification submitted by Capnia, Inc. for the device "COSENSE CO MONITOR". The FDA issued a decision of Substantially Equivalent on January 14, 2014. 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
- January 14, 2014
- Date Received
- January 7, 2013
- Clearance Type
- Traditional
- 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