510(k) K790657
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 1979
- Date Received
- April 5, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chamber, Patient Isolation
- Device Class
- Class II
- Regulation Number
- 880.5450
- Review Panel
- HO
- Submission Type