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510(k) K900553

CONSTANT CURRENT STIMULATOR MODEL 022101 by Ep Technologies, Inc. — Product Code JOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1990
Date Received
February 6, 1990
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)