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FDA 510(k)

ELECTRODE USING PROMEON RG-60 SERIES GEL

K-Number: K915333 · 1992-01-14

ApplicantLabeltape Meditect, Inc.
Decision Date1992-01-14
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTRODE USING PROMEON RG-60 SERIES GEL is the device name listed in this FDA 510(k) record. The listed applicant is Labeltape Meditect, Inc.. It received FDA 510(k) clearance on 1992-01-14 under 510(k) number K915333. 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 ELECTRODE USING PROMEON RG-60 SERIES GEL?

ELECTRODE USING PROMEON RG-60 SERIES GEL is a medical device that received FDA 510(k) clearance on 1992-01-14. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K915333.

When did ELECTRODE USING PROMEON RG-60 SERIES GEL receive FDA 510(k) clearance?

ELECTRODE USING PROMEON RG-60 SERIES GEL received FDA 510(k) clearance on 1992-01-14, under 510(k) number K915333.

Who is the listed applicant for ELECTRODE USING PROMEON RG-60 SERIES GEL?

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

What is the FDA product code for ELECTRODE USING PROMEON RG-60 SERIES GEL?

The FDA product code for ELECTRODE USING PROMEON RG-60 SERIES GEL is 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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