510(k) K770084
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 1977
- Date Received
- January 14, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Air Handling, Room
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- SU
- Submission Type