510(k) K964540
Clearance Details
- Decision
- ST ()
- Decision Date
- November 14, 1997
- Date Received
- November 12, 1996
- 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