510(k) K003576
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2001
- Date Received
- November 20, 2000
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector And Alarm, Arrhythmia
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type