510(k) K760518
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 1976
- Date Received
- August 26, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Oxygen, Low Concentration, Venturi
- Device Class
- Class I
- Regulation Number
- 868.5600
- Review Panel
- AN
- Submission Type