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FDA 510(k)

ELEFIX ELECTRODE CREAM

K-Number: K860210 · 1986-07-01

ApplicantNihon Kohden America, Inc.
Decision Date1986-07-01
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELEFIX ELECTRODE CREAM is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1986-07-01 under 510(k) number K860210. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEFIX ELECTRODE CREAM?

ELEFIX ELECTRODE CREAM is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K860210.

When did ELEFIX ELECTRODE CREAM receive FDA 510(k) clearance?

ELEFIX ELECTRODE CREAM received FDA 510(k) clearance on 1986-07-01, under 510(k) number K860210.

Who is the listed applicant for ELEFIX ELECTRODE CREAM?

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

What is the FDA product code for ELEFIX ELECTRODE CREAM?

The FDA product code for ELEFIX ELECTRODE CREAM is GYB.

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Other records listing Nihon Kohden America, Inc. as applicant

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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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