510(k) K083228
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2008
- Date Received
- November 3, 2008
- Clearance Type
- Special
- 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