510(k) K060739
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2006
- Date Received
- March 20, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chamber, Hyperbaric
- Device Class
- Class II
- Regulation Number
- 868.5470
- Review Panel
- AN
- Submission Type