WISCONSIN HEART RATE MONITOR— 510(k) K802182

Substantially Equivalent

Lunar Radiation Corp.

FDA 510(k) clearance K802182 for WISCONSIN HEART RATE MONITOR, Substantially Equivalent on 1980-10-31. Applicant: Lunar Radiation Corp..

Clearance details

Applicant: Lunar Radiation Corp.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1980-09-09
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.