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FDA 510(k)

ELECTRODE, ELECTROCARDIOGRAPH

K-Number: K973727 · 1997-12-19

ApplicantDon Tay Industries
Decision Date1997-12-19
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRODE, ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Don Tay Industries. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K973727. 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 ELECTRODE, ELECTROCARDIOGRAPH?

ELECTRODE, ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Don Tay Industries. The 510(k) number is K973727.

When did ELECTRODE, ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

ELECTRODE, ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1997-12-19, under 510(k) number K973727.

Who is the listed applicant for ELECTRODE, ELECTROCARDIOGRAPH?

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

What is the FDA product code for ELECTRODE, ELECTROCARDIOGRAPH?

The FDA product code for ELECTRODE, ELECTROCARDIOGRAPH 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

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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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