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FDA 510(k)

WISCONSIN HEART RATE MONITOR

K-Number: K802182 · 1980-10-31

Decision Date1980-10-31
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WISCONSIN HEART RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Lunar Radiation Corp.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802182. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WISCONSIN HEART RATE MONITOR?

WISCONSIN HEART RATE MONITOR is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Lunar Radiation Corp.. The 510(k) number is K802182.

When did WISCONSIN HEART RATE MONITOR receive FDA 510(k) clearance?

WISCONSIN HEART RATE MONITOR received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802182.

Who is the listed applicant for WISCONSIN HEART RATE MONITOR?

The FDA 510(k) record lists Lunar Radiation Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WISCONSIN HEART RATE MONITOR?

The FDA product code for WISCONSIN HEART RATE MONITOR is DRT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Lunar Radiation Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: DRT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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