510(k) K162877
K162877 is an FDA 510(k) premarket notification submitted by Ventec Life Systems, Inc. for the device "VOCSN Unified Respiratory System". The FDA issued a decision of Substantially Equivalent on April 7, 2017. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2017
- Date Received
- October 14, 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