510(k) K850924
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1985
- Date Received
- March 5, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Breathing Tube
- Device Class
- Class I
- Regulation Number
- 868.5280
- Review Panel
- AN
- Submission Type