CARDIO-RESPIRATORY MONITOR MODEL CR-1— 510(k) K821959

Substantially Equivalent

Electromed Intl., Ltd.

FDA 510(k) clearance K821959 for CARDIO-RESPIRATORY MONITOR MODEL CR-1, Substantially Equivalent on 1982-07-20. Applicant: Electromed Intl., Ltd..

Clearance details

Applicant: Electromed Intl., Ltd.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1982-06-30
Decision date: 1982-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.