510(k) K940323

ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM by Arbo Medical, Inc. — Product Code DSA

K940323 is an FDA 510(k) premarket notification submitted by Arbo Medical, Inc. for the device "ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM". The FDA issued a decision of Substantially Equivalent on April 12, 1995. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Arbo Medical, Inc. has at least 10 other 510(k) clearances on record.

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