510(k) K990429
Clearance Details
- Decision
- ST ()
- Decision Date
- February 24, 1999
- Date Received
- February 11, 1999
- Clearance Type
- Special
- 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