510(k) K093261
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2010
- Date Received
- October 19, 2009
- Clearance Type
- Traditional
- Expedited Review
- Yes
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Emergency, Powered (Resuscitator)
- Device Class
- Class II
- Regulation Number
- 868.5925
- Review Panel
- AN
- Submission Type