510(k) K070232

ECG CABLES, TRUNK AND PATIENT LEAD WIRES by American I.V. Products, Inc. — Product Code DSA

K070232 is an FDA 510(k) premarket notification submitted by American I.V. Products, Inc. for the device "ECG CABLES, TRUNK AND PATIENT LEAD WIRES". The FDA issued a decision of Substantially Equivalent on March 27, 2007. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. American I.V. Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2007
Date Received
January 24, 2007
Clearance Type
Abbreviated
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