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510(k) K933073

HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE by Heartware Intl. Corp. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1993
Date Received
June 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

Other clearances by Heartware Intl. Corp.

  • K932410 — HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SY (December 13, 1993)
  • K933058 — HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW (September 28, 1993)
  • K893094 — HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM (October 2, 1989)

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