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510(k) K230184

Holter ECG and ABP System by Edan Instruments, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2023
Date Received
January 23, 2023
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 Edan Instruments, Inc.

  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (December 23, 2025)
  • K241882 — Fetal & Maternal Monitor (F15A, F15A Air) (August 27, 2025)
  • K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (July 29, 2025)
  • K250214 — Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix (February 20, 2025)
  • K240320 — Patient Monitor (RespArray) (June 28, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K232962 — Patient Monitor (iX10, iX12, iX15) (April 19, 2024)
  • K233038 — Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s (March 8, 2024)
  • K232694 — Central Monitoring System (MFM-CMS) (February 5, 2024)

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)
  • K231289 — S-Patch Ex Wearable ECG Patch (August 30, 2023)
  • K223382 — AeviceMD (July 7, 2023)