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510(k) K910307

CARDIOLAB AMPLIFIER MODULE (CAM) by Prucka Engineering, Inc. — Product Code DRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1991
Date Received
January 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Biopotential
Device Class
Class II
Regulation Number
870.2050
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)
  • K902716 — PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) (September 4, 1990)
  • K895916 — PE INTERCARDIAC MAPPING SYSTEM (ICMS) (December 13, 1989)

Other clearances for product code DRR

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  • K971570 — EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 (December 29, 1997)
  • K925346 — EP AMP, MODEL #901 (April 30, 1993)
  • K914381 — HORIZON 9000/HIS OPTION AMPLIFIER (January 28, 1992)
  • K911935 — CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED (July 22, 1991)
  • K894735 — ASC-952 PHYSIOLOGICAL AMPLIFIER (September 18, 1989)
  • K894161 — ASC-950 ECG AMPLIFIER (August 3, 1989)
  • K874441 — BARD BIOPOTENTIAL AMPLIFIER (January 19, 1988)
  • K853652 — BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT (January 16, 1986)
  • K813123 — EPC FILTER (November 27, 1981)