510(k) K123144
K123144 is an FDA 510(k) premarket notification submitted by Ge Healthcare, Breas Medical AB for the device "VIVO 50". The FDA issued a decision of Substantially Equivalent on June 18, 2013. The device falls under product code NOU (Continuous, Ventilator, Home Use), a Class II device regulated under 21 CFR 868.5895.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2013
- Date Received
- October 5, 2012
- 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.