CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM— 510(k) K850136

Substantially Equivalent

Cardio Data

FDA 510(k) clearance K850136 for CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM, Substantially Equivalent on 1985-02-01. Applicant: Cardio Data.

Clearance details

Applicant: Cardio Data
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1985-01-14
Decision date: 1985-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malboro, MA, US

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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.