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510(k) K893094

HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM by Heartware Intl. Corp. — Product Code JOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1989
Date Received
April 28, 1989
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

Other clearances by Heartware Intl. Corp.

  • K932410 — HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY (December 13, 1993)
  • K933073 — HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE (October 7, 1993)
  • K933058 — HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW (September 28, 1993)

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  • K963579 — PACE-1A CARDIAC STIMULATOR (November 8, 1996)
  • K935590 — EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR (May 5, 1994)