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510(k) K813602

HOLTER PERFORMER by Applied Cardiac Systems — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1982
Date Received
December 28, 1981
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 Applied Cardiac Systems

  • K103706 — THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR (August 24, 2011)
  • K042413 — ACS MODEL NCP-2 (December 9, 2004)
  • K860249 — THE HOLTER REPORTER (TM) (March 11, 1986)
  • K833823 — HOLTER PERFORMER FEATHER WEIGHT/CASS (December 1, 1983)

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)