HOLTER ST SYSTEM, MODEL NO. 5000-20— 510(k) K871389

Name: FDA 510(k) clearance K871389
Creator: U.S. Food and Drug Administration
Published: 1987-09-01

Substantially Equivalent

Holter Data Services

FDA 510(k) clearance K871389 for HOLTER ST SYSTEM, MODEL NO. 5000-20, Substantially Equivalent on 1987-09-01. Applicant: Holter Data Services. Device class: 2.

Clearance details

Applicant: Holter Data Services
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1987-04-07
Decision date: 1987-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSI

view all

K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0)2026-01-23
K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)2025-07-29
K240177 — Zio AT® device (A100A1001)2024-10-30
K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System2023-10-06
K231276 — SmartCardia 7L Platform2023-08-30

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.