510(k) K093388
K093388 is an FDA 510(k) premarket notification submitted by Oridion Medical 1987 , Ltd. for the device "SMART CAPNOLINE GUARDIAN". The FDA issued a decision of Substantially Equivalent on March 4, 2010. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Oridion Medical 1987 , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2010
- Date Received
- October 30, 2009
- 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