510(k) K093268
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2010
- Date Received
- October 19, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type