510(k) K163127
K163127 is an FDA 510(k) premarket notification submitted by Imtmedical AG for the device "bellavista 1000". The FDA issued a decision of Substantially Equivalent on Jul 31, 2017. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Imtmedical AG has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 31, 2017
- Date Received
- Nov 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type
- 510(k)