510(k) K896721
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 1990
- Date Received
- November 28, 1989
- 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