FDA 510(k)

BATCH #6060 CONDUCTIVE GEL

K-Number: K983964 · 1998-12-09

Decision Date1998-12-09

Product CodeGYB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BATCH #6060 CONDUCTIVE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Skylark Device Co., Ltd.. It received FDA 510(k) clearance on 1998-12-09 under 510(k) number K983964. 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 BATCH #6060 CONDUCTIVE GEL?

BATCH #6060 CONDUCTIVE GEL is a medical device that received FDA 510(k) clearance on 1998-12-09. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K983964.

When did BATCH #6060 CONDUCTIVE GEL receive FDA 510(k) clearance?

BATCH #6060 CONDUCTIVE GEL received FDA 510(k) clearance on 1998-12-09, under 510(k) number K983964.

Who is the listed applicant for BATCH #6060 CONDUCTIVE GEL?

The FDA 510(k) record lists Skylark Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BATCH #6060 CONDUCTIVE GEL?

The FDA product code for BATCH #6060 CONDUCTIVE GEL is GYB.

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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.