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FDA 510(k)

M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40

K-Number: K884984 · 1989-03-09

ApplicantS & W Medico Teknik
Decision Date1989-03-09
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 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 1989-03-09 under 510(k) number K884984. 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 M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40?

M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 is a medical device that received FDA 510(k) clearance on 1989-03-09. The listed applicant is S & W Medico Teknik. The 510(k) number is K884984.

When did M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 receive FDA 510(k) clearance?

M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 received FDA 510(k) clearance on 1989-03-09, under 510(k) number K884984.

Who is the listed applicant for M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40?

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 M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40?

The FDA product code for M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 is DRX.

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Related Devices (Code: DRX)

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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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