510(k) K935518
Clearance Details
- Decision
- ST ()
- Decision Date
- May 17, 1994
- Date Received
- November 3, 1993
- 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