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FDA 510(k)

DISPOSABLE ELECTRODE FOR EKG

K-Number: K803179 · 1981-03-11

ApplicantMidwest Monitoring
Decision Date1981-03-11
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ELECTRODE FOR EKG is the device name listed in this FDA 510(k) record. The listed applicant is Midwest Monitoring. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K803179. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE ELECTRODE FOR EKG?

DISPOSABLE ELECTRODE FOR EKG is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Midwest Monitoring. The 510(k) number is K803179.

When did DISPOSABLE ELECTRODE FOR EKG receive FDA 510(k) clearance?

DISPOSABLE ELECTRODE FOR EKG received FDA 510(k) clearance on 1981-03-11, under 510(k) number K803179.

Who is the listed applicant for DISPOSABLE ELECTRODE FOR EKG?

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

What is the FDA product code for DISPOSABLE ELECTRODE FOR EKG?

The FDA product code for DISPOSABLE ELECTRODE FOR EKG is DRX.

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Related Devices (Code: DRX)

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.

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Official Source

View on FDA Database →

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

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