510(k) K981376
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 1999
- Date Received
- April 16, 1998
- Clearance Type
- Traditional
- 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