510(k) K083617
K083617 is an FDA 510(k) premarket notification submitted by Apieron, Inc. for the device "APIERON INSIGHT ENO SYSTEM". The FDA issued a decision of Substantially Equivalent on January 27, 2009. The device falls under product code MXA (System, Test, Breath Nitric Oxide), a Class II device regulated under 21 CFR 862.3080. Apieron, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2009
- Date Received
- December 8, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Breath Nitric Oxide
- Device Class
- Class II
- Regulation Number
- 862.3080
- Review Panel
- CH
- Submission Type