510(k) K861158
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 1986
- Date Received
- March 28, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2360
- Review Panel
- CV
- Submission Type