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FDA 510(k)

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)

K-Number: K182631 · 2019-09-19

ApplicantEurogreen International, Inc.
Decision Date2019-09-19
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) is the device name listed in this FDA 510(k) record. The listed applicant is Eurogreen International, Inc.. It received FDA 510(k) clearance on 2019-09-19 under 510(k) number K182631. 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 SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)?

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) is a medical device that received FDA 510(k) clearance on 2019-09-19. The listed applicant is Eurogreen International, Inc.. The 510(k) number is K182631.

When did SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) receive FDA 510(k) clearance?

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) received FDA 510(k) clearance on 2019-09-19, under 510(k) number K182631.

Who is the listed applicant for SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)?

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

What is the FDA product code for SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)?

The FDA product code for SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) is INI.

Other records listing Eurogreen International, 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.

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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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