510(k) K935126
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1994
- Date Received
- October 28, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tent, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5700
- Review Panel
- AN
- Submission Type