510(k) K791861
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1979
- Date Received
- September 24, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hood, Oxygen, Infant
- Device Class
- Class I
- Regulation Number
- 868.5700
- Review Panel
- AN
- Submission Type