510(k) K953238
Clearance Details
- Decision
- ST ()
- Decision Date
- September 16, 1996
- Date Received
- July 11, 1995
- 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