510(k) K930786
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1994
- Date Received
- February 16, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Lead Switching, Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2350
- Review Panel
- CV
- Submission Type