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510(k) K202456

M5 Recorder by Global Instrumentation, LLC — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2020
Date Received
August 27, 2020
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Global Instrumentation, LLC

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  • K152701 — Matrix Mini ECG Monitor (April 22, 2016)
  • K051730 — MATRIX HOLTER SYSTEM, MODEL M12 (September 26, 2005)

Other clearances for product code DSH

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  • 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)