510(k) K081266
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2009
- Date Received
- May 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Attachment, Breathing, Positive End Expiratory Pressure
- Device Class
- Class II
- Regulation Number
- 868.5965
- Review Panel
- AN
- Submission Type