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FDA 510(k)

PROTENS ELECTRODE

K-Number: K042301 · 2004-09-03

ApplicantBio Protech, Inc.
Decision Date2004-09-03
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PROTENS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Bio Protech, Inc.. It received FDA 510(k) clearance on 2004-09-03 under 510(k) number K042301. 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 PROTENS ELECTRODE?

PROTENS ELECTRODE is a medical device that received FDA 510(k) clearance on 2004-09-03. The listed applicant is Bio Protech, Inc.. The 510(k) number is K042301.

When did PROTENS ELECTRODE receive FDA 510(k) clearance?

PROTENS ELECTRODE received FDA 510(k) clearance on 2004-09-03, under 510(k) number K042301.

Who is the listed applicant for PROTENS ELECTRODE?

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

What is the FDA product code for PROTENS ELECTRODE?

The FDA product code for PROTENS ELECTRODE is GXY.

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Related Devices (Code: GXY)

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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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