510(k) K131506
K131506 is an FDA 510(k) premarket notification submitted by Abeon Medical Corporation for the device "AIRWAY SUPPORT SYSTEM / AIRPORT". The FDA issued a decision of Substantially Equivalent on March 6, 2014. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Abeon Medical Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2014
- Date Received
- May 24, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1400
- Review Panel
- AN
- Submission Type