510(k) K140430
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2014
- Date Received
- February 19, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type