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FDA 510(k)

BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED

K-Number: K041025 · 2004-05-03

Decision Date2004-05-03
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED is the device name listed in this FDA 510(k) record. The listed applicant is Golden Technologies, Inc.. It received FDA 510(k) clearance on 2004-05-03 under 510(k) number K041025. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED?

BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED is a medical device that received FDA 510(k) clearance on 2004-05-03. The listed applicant is Golden Technologies, Inc.. The 510(k) number is K041025.

When did BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED receive FDA 510(k) clearance?

BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED received FDA 510(k) clearance on 2004-05-03, under 510(k) number K041025.

Who is the listed applicant for BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED?

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

What is the FDA product code for BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED?

The FDA product code for BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED is INI.

Related Clinical Trials

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.

Other records listing Golden Technologies, Inc. as applicant

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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Related Devices (Code: INI)

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.

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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