510(k) K062577

V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC by Tz Medical, Inc. — Product Code DSA

K062577 is an FDA 510(k) premarket notification submitted by Tz Medical, Inc. for the device "V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC". The FDA issued a decision of Substantially Equivalent on December 15, 2006. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Tz Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2006
Date Received
August 31, 2006
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