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

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.).

Clearance details

Applicant: Rmv Medical (Romavat, Inc.)
Product code: Code DSI
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 ↗

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.