510(k) K160481
K160481 is an FDA 510(k) premarket notification submitted by Breas Medical AB for the device "Vivo 60". The FDA issued a decision of Substantially Equivalent on November 9, 2016. The device falls under product code NOU (Continuous, Ventilator, Home Use), 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
- November 9, 2016
- Date Received
- February 22, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Continuous, Ventilator, Home Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type
This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.