510(k) K203695
K203695 is an FDA 510(k) premarket notification submitted by Bedfont Scientific, Ltd. for the device "NObreath®". The FDA issued a decision of Substantially Equivalent on December 17, 2021. The device falls under product code MXA (System, Test, Breath Nitric Oxide), a Class II device regulated under 21 CFR 862.3080. Bedfont Scientific, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2021
- Date Received
- December 18, 2020
- 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