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FDA 510(k)

BIOPOTENTIAL SURFACE ELECTRODE

K-Number: K900059 · 1990-02-22

ApplicantIntegral Design, Inc.
Decision Date1990-02-22
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOPOTENTIAL SURFACE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Integral Design, Inc.. It received FDA 510(k) clearance on 1990-02-22 under 510(k) number K900059. 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 SURFACE ELECTRODE?

BIOPOTENTIAL SURFACE ELECTRODE is a medical device that received FDA 510(k) clearance on 1990-02-22. The listed applicant is Integral Design, Inc.. The 510(k) number is K900059.

When did BIOPOTENTIAL SURFACE ELECTRODE receive FDA 510(k) clearance?

BIOPOTENTIAL SURFACE ELECTRODE received FDA 510(k) clearance on 1990-02-22, under 510(k) number K900059.

Who is the listed applicant for BIOPOTENTIAL SURFACE ELECTRODE?

The FDA 510(k) record lists Integral Design, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPOTENTIAL SURFACE ELECTRODE?

The FDA product code for BIOPOTENTIAL SURFACE ELECTRODE is GXY.

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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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