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510(k) K971570

EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 by Quinton Electrophysiology Corp. — Product Code DRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1997
Date Received
April 29, 1997
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 Quinton Electrophysiology Corp.

  • K925346 — EP AMP, MODEL #901 (April 30, 1993)
  • K893836 — EPLAB (ELECTROCARDIOGRAPHIC MONITOR) (September 8, 1989)

Other clearances for product code DRR

  • K022660 — BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (December 19, 2002)
  • 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)
  • K910307 — CARDIOLAB AMPLIFIER MODULE (CAM) (April 12, 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)