510(k) K960934
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 1996
- Date Received
- March 8, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, St Segment With Alarm
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type