510(k) K240779
K240779 is an FDA 510(k) premarket notification submitted by Breas Medical AB for the device "Vivo 3". The FDA issued a decision of Substantially Equivalent on December 13, 2024. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Breas Medical AB has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2024
- Date Received
- March 21, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sv70 Ventilator
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type