510(k) K981971
Clearance Details
- Decision
- ST ()
- Decision Date
- August 24, 1998
- Date Received
- June 4, 1998
- 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