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FDA 510(k)

BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150

K-Number: K991199 · 1999-06-22

ApplicantBiomed Products
Decision Date1999-06-22
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 is the device name listed in this FDA 510(k) record. The listed applicant is Biomed Products. It received FDA 510(k) clearance on 1999-06-22 under 510(k) number K991199. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150?

BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 is a medical device that received FDA 510(k) clearance on 1999-06-22. The listed applicant is Biomed Products. The 510(k) number is K991199.

When did BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 receive FDA 510(k) clearance?

BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 received FDA 510(k) clearance on 1999-06-22, under 510(k) number K991199.

Who is the listed applicant for BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150?

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

What is the FDA product code for BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150?

The FDA product code for BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 is GXY.

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Official Source

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