510(k) K842303
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 1984
- Date Received
- June 11, 1984
- Clearance Type
- Traditional
- 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