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510(k) K963669

GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM by Astro-Med, Inc. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1996
Date Received
September 13, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

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  • 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)
  • K894735 — ASC-952 PHYSIOLOGICAL AMPLIFIER (September 18, 1989)

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