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510(k) K892067

MT9000 CHART RECORDER by Astro-Med, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1989
Date Received
March 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
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 DSH

  • K253293 — VitaloJAK Clinic (Model 7100) (December 3, 2025)
  • K243650 — Zio® monitor (DFG0001) (August 15, 2025)
  • K243603 — AeviceMD (May 5, 2025)
  • K242583 — AT-Patch (ATP-C130/ATP-C70) (May 2, 2025)
  • K232670 — HiCardi+ H100 (September 20, 2024)
  • K233906 — S-Patch (S-Patch ExL) (February 16, 2024)
  • K231104 — ABPMpro (November 27, 2023)
  • K233110 — Carnation Ambulatory Monitor (November 22, 2023)
  • K230184 — Holter ECG and ABP System (September 25, 2023)
  • K231289 — S-Patch Ex Wearable ECG Patch (August 30, 2023)