HOLTER 24-HOUR ECG PLAYBACK, MODEL 150— 510(k) K884539

Name: FDA 510(k) clearance K884539
Creator: U.S. Food and Drug Administration
Published: 1989-01-17

Substantially Equivalent

Rmv Medical (Romavat, Inc.)

FDA 510(k) clearance K884539 for HOLTER 24-HOUR ECG PLAYBACK, MODEL 150, Substantially Equivalent on 1989-01-17. Applicant: Rmv Medical (Romavat, Inc.). Device class: 2.

Clearance details

Applicant: Rmv Medical (Romavat, Inc.)
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1988-10-28
Decision date: 1989-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSI

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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.