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510(k) K934644

K3 SYSTEM by Astro-Med, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1994
Date Received
September 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
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)
  • 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)
  • K894735 — ASC-952 PHYSIOLOGICAL AMPLIFIER (September 18, 1989)

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