C/PES 9103, ECG STRESS TESTING SYSTEM— 510(k) K850113

Substantially Equivalent

Gould, Inc.

FDA 510(k) clearance K850113 for C/PES 9103, ECG STRESS TESTING SYSTEM, Substantially Equivalent on 1985-02-08. Applicant: Gould, Inc..

Clearance details

Applicant: Gould, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1985-01-14
Decision date: 1985-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.