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510(k) K070743

Z6 STIMULATOR by St Cardio Technologies, LLC — Product Code JOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2007
Date Received
March 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Device Class
Class II
Regulation Number
870.1750
Review Panel
CV
Submission Type

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  • K963579 — PACE-1A CARDIAC STIMULATOR (November 8, 1996)
  • K935590 — EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR (May 5, 1994)
  • K900553 — CONSTANT CURRENT STIMULATOR MODEL 022101 (March 13, 1990)