510(k) K940323
ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM by
Arbo Medical, Inc.
— Product Code DSA
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1995
- Date Received
- January 24, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cable, Transducer And Electrode, Patient, (Including Connector)
- Device Class
- Class II
- Regulation Number
- 870.2900
- Review Panel
- CV
- Submission Type