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510(k) K902716

PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) by Prucka Engineering, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1990
Date Received
June 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
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)
  • K895916 — PE INTERCARDIAC MAPPING SYSTEM (ICMS) (December 13, 1989)

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