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FDA 510(k)

BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP

K-Number: K063060 · 2006-11-29

ApplicantBlueshine Srl
Decision Date2006-11-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP is the device name listed in this FDA 510(k) record. The listed applicant is Blueshine Srl. It received FDA 510(k) clearance on 2006-11-29 under 510(k) number K063060. 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 LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP?

BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP is a medical device that received FDA 510(k) clearance on 2006-11-29. The listed applicant is Blueshine Srl. The 510(k) number is K063060.

When did BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP receive FDA 510(k) clearance?

BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP received FDA 510(k) clearance on 2006-11-29, under 510(k) number K063060.

Who is the listed applicant for BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP?

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 LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP?

The FDA product code for BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP is GEX. This falls under the Gastroenterology category.

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.

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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 SERIESK090297BLUESHINE GOLD SERIES

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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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