510(k) K940223
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1994
- Date Received
- January 18, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Environmental Control, Powered
- Device Class
- Class II
- Regulation Number
- 890.3725
- Review Panel
- PM
- Submission Type