510(k) K213611
K213611 is an FDA 510(k) premarket notification submitted by Caire Diagnostics, Inc. for the device "Fenom Pro". The FDA issued a decision of Substantially Equivalent on June 7, 2023. The device falls under product code MXA (System, Test, Breath Nitric Oxide), a Class II device regulated under 21 CFR 862.3080.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2023
- Date Received
- November 15, 2021
- Clearance Type
- Traditional
- 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