510(k) K972746
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1997
- Date Received
- July 23, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type