510(k) K240807
K240807 is an FDA 510(k) premarket notification submitted by Ventis Medical, Inc. for the device "VM-2000". The FDA issued a decision of Substantially Equivalent on August 13, 2024. 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
- August 13, 2024
- Date Received
- March 25, 2024
- 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