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FDA 510(k)

FI, GORDY TOY, WELLJOY AND OTHERS

K-Number: K946004 · 1995-01-31

ApplicantFundamental Industrial Co., Ltd.
Decision Date1995-01-31
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FI, GORDY TOY, WELLJOY AND OTHERS is the device name listed in this FDA 510(k) record. The listed applicant is Fundamental Industrial Co., Ltd.. It received FDA 510(k) clearance on 1995-01-31 under 510(k) number K946004. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FI, GORDY TOY, WELLJOY AND OTHERS?

FI, GORDY TOY, WELLJOY AND OTHERS is a medical device that received FDA 510(k) clearance on 1995-01-31. The listed applicant is Fundamental Industrial Co., Ltd.. The 510(k) number is K946004.

When did FI, GORDY TOY, WELLJOY AND OTHERS receive FDA 510(k) clearance?

FI, GORDY TOY, WELLJOY AND OTHERS received FDA 510(k) clearance on 1995-01-31, under 510(k) number K946004.

Who is the listed applicant for FI, GORDY TOY, WELLJOY AND OTHERS?

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

What is the FDA product code for FI, GORDY TOY, WELLJOY AND OTHERS?

The FDA product code for FI, GORDY TOY, WELLJOY AND OTHERS is HQY.

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Related Devices (Code: HQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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