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510(k) K896164

ASC-954 INTEGRATOR AMPLIFIER by Astro-Med, Inc. — Product Code GWK

K896164 is an FDA 510(k) premarket notification submitted by Astro-Med, Inc. for the device "ASC-954 INTEGRATOR AMPLIFIER". The FDA issued a decision of Substantially Equivalent on January 22, 1990. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Astro-Med, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1990
Date Received
October 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conditioner, Signal, Physiological
Device Class
Class II
Regulation Number
882.1845
Review Panel
NE
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)
  • K894295 — ASTRO-MED ASC-951 PRESSURE PROCESSOR (January 18, 1990)
  • K894736 — MT96000 PAPER CHART RECORDER (December 13, 1989)
  • K894735 — ASC-952 PHYSIOLOGICAL AMPLIFIER (September 18, 1989)

Other clearances for product code GWK

  • K060919 — ACTICAL (September 22, 2006)
  • K061870 — VITALSENSE XHR (August 31, 2006)
  • K052489 — ACTIHEART (September 27, 2005)
  • K991045 — MINI-LOGGER SERIES 2000 (September 21, 1999)
  • K905594 — NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 (June 28, 1991)
  • K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (June 18, 1991)
  • K882599 — NICOLET BRAINLAB SYSTEM (October 19, 1988)
  • K872290 — BIO-LOGIC BANKER (October 6, 1987)
  • K870381 — DD-VCR-64 (March 25, 1987)
  • K860914 — ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV (June 6, 1986)

FDA data resources