510(k) K895485
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1989
- Date Received
- September 11, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Positive Pressure Breathing, Intermittent
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type