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FDA 510(k)

F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM

K-Number: K884980 · 1989-05-01

ApplicantS & W Medico Teknik
Decision Date1989-05-01
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM is the device name listed in this FDA 510(k) record. The listed applicant is S & W Medico Teknik. It received FDA 510(k) clearance on 1989-05-01 under 510(k) number K884980. 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 F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM?

F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM is a medical device that received FDA 510(k) clearance on 1989-05-01. The listed applicant is S & W Medico Teknik. The 510(k) number is K884980.

When did F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM receive FDA 510(k) clearance?

F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM received FDA 510(k) clearance on 1989-05-01, under 510(k) number K884980.

Who is the listed applicant for F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM?

The FDA 510(k) record lists S & W Medico Teknik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM?

The FDA product code for F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM 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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