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510(k) K960321

CARDIOCATH CATHETERIZATION LAB SYSTEM by Prucka Engineering, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1996
Date Received
January 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Prucka Engineering, Inc.

  • K993414 — PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 (April 7, 2000)
  • K904747 — PEI PLAQUE ELECTRODE ARRAY (October 9, 1991)
  • K910307 — CARDIOLAB AMPLIFIER MODULE (CAM) (April 12, 1991)
  • K902716 — PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) (September 4, 1990)
  • K895916 — PE INTERCARDIAC MAPPING SYSTEM (ICMS) (December 13, 1989)

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