INFANT ECG ELECTRODE #60-1029— 510(k) K810102

Substantially Equivalent

Aspen Laboratories, Inc.

FDA 510(k) clearance K810102 for INFANT ECG ELECTRODE #60-1029, Substantially Equivalent on 1981-01-29. Applicant: Aspen Laboratories, Inc..

Clearance details

Applicant: Aspen Laboratories, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1981-01-16
Decision date: 1981-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.