510(k) K002598
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2000
- Date Received
- August 21, 2000
- Clearance Type
- Special
- 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