510(k) K781216
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1978
- Date Received
- July 17, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Apnea, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.2377
- Review Panel
- AN
- Submission Type