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510(k) K895916

PE INTERCARDIAC MAPPING SYSTEM (ICMS) by Prucka Engineering, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1989
Date Received
October 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Prucka Engineering, Inc.

  • K993414 — PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 (April 7, 2000)
  • K960321 — CARDIOCATH CATHETERIZATION LAB SYSTEM (August 21, 1996)
  • 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)

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