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FDA 510(k)

BLUESHINE GOLD SERIES

K-Number: K090297 · 2009-04-14

ApplicantBlueshine Srl
Decision Date2009-04-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLUESHINE GOLD SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Blueshine Srl. It received FDA 510(k) clearance on 2009-04-14 under 510(k) number K090297. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLUESHINE GOLD SERIES?

BLUESHINE GOLD SERIES is a medical device that received FDA 510(k) clearance on 2009-04-14. The listed applicant is Blueshine Srl. The 510(k) number is K090297.

When did BLUESHINE GOLD SERIES receive FDA 510(k) clearance?

BLUESHINE GOLD SERIES received FDA 510(k) clearance on 2009-04-14, under 510(k) number K090297.

Who is the listed applicant for BLUESHINE GOLD SERIES?

The FDA 510(k) record lists Blueshine Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUESHINE GOLD SERIES?

The FDA product code for BLUESHINE GOLD SERIES is GEX. This falls under the Gastroenterology category.

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Other records listing Blueshine Srl 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.

K110375BLUESHINE'S GOLD SERIESK063060BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP

Related Devices (Code: GEX)

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

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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