510(k) K121597
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2012
- Date Received
- May 31, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Non-Continuous (Respirator)
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type