Home / 510(k) Clearances / K894161

510(k) K894161

ASC-950 ECG AMPLIFIER by Astro-Med, Inc. — Product Code DRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1989
Date Received
June 14, 1989
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 Astro-Med, Inc.

  • K081551 — TWIN NEUROTRAC-III (December 24, 2008)
  • K050425 — AURA-PSG (October 20, 2005)
  • K033978 — ADAM (February 18, 2004)
  • K970951 — GRASS BRAINWAVE SOFTWARE (May 19, 1997)
  • K963669 — GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM (December 12, 1996)
  • K934644 — K3 SYSTEM (November 1, 1994)
  • K912929 — DASH IV (August 13, 1991)
  • K896164 — ASC-954 INTEGRATOR AMPLIFIER (January 22, 1990)
  • K894295 — ASTRO-MED ASC-951 PRESSURE PROCESSOR (January 18, 1990)
  • K894736 — MT96000 PAPER CHART RECORDER (December 13, 1989)

Other clearances for product code DRR

  • K022660 — BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (December 19, 2002)
  • 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)
  • K910307 — CARDIOLAB AMPLIFIER MODULE (CAM) (April 12, 1991)
  • K894735 — ASC-952 PHYSIOLOGICAL AMPLIFIER (September 18, 1989)
  • K874441 — BARD BIOPOTENTIAL AMPLIFIER (January 19, 1988)
  • K853652 — BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT (January 16, 1986)
  • K813123 — EPC FILTER (November 27, 1981)