510(k) K112622
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2012
- Date Received
- September 8, 2011
- 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