510(k) K832131
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 1983
- Date Received
- July 1, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type