510(k) K924875
Clearance Details
- Decision
- ST ()
- Decision Date
- June 30, 1994
- Date Received
- September 14, 1992
- 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