4-CHANNEL ECG TELEMETRY MON. SYST. #3045— 510(k) K803229

Substantially Equivalent

Cambridge Instruments, Inc.

FDA 510(k) clearance K803229 for 4-CHANNEL ECG TELEMETRY MON. SYST. #3045, Substantially Equivalent on 1981-01-13. Applicant: Cambridge Instruments, Inc..

Clearance details

Applicant: Cambridge Instruments, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 1980-12-19
Decision date: 1981-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.