510(k) K924174
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 1992
- Date Received
- August 19, 1992
- 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