510(k) K042782
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2005
- Date Received
- October 6, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph, Ambulatory, With Analysis Algorithm
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type