PROPAQ ECG TELEMETRY OPTION— 510(k) K934711

Substantially Equivalent

Protocol Systems, Inc.

FDA 510(k) clearance K934711 for PROPAQ ECG TELEMETRY OPTION, Substantially Equivalent on 1994-09-01. Applicant: Protocol Systems, Inc..

Clearance details

Applicant: Protocol Systems, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 1993-10-01
Decision date: 1994-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, US

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.