510(k) K052751
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2005
- Date Received
- September 30, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory To Continuous Ventilator (Respirator)
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type