510(k) K812873
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1981
- Date Received
- October 14, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type