510(k) K122333
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2012
- Date Received
- August 2, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 870.2910
- Review Panel
- CV
- Submission Type