510(k) K233775
K233775 is an FDA 510(k) premarket notification submitted by Bosch Healthcare Solutions GmbH for the device "Vivatmo pro". The FDA issued a decision of Substantially Equivalent on February 22, 2024. The device falls under product code MXA (System, Test, Breath Nitric Oxide), a Class II device regulated under 21 CFR 862.3080. Bosch Healthcare Solutions GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2024
- Date Received
- November 24, 2023
- 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