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FDA 510(k)

BM.IRIS

K-Number: K171648 · 2017-09-08

ApplicantBluecore Co., Ltd.
Decision Date2017-09-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BM.IRIS is the device name listed in this FDA 510(k) record. The listed applicant is Bluecore Co., Ltd.. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K171648. 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 BM.IRIS?

BM.IRIS is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Bluecore Co., Ltd.. The 510(k) number is K171648.

When did BM.IRIS receive FDA 510(k) clearance?

BM.IRIS received FDA 510(k) clearance on 2017-09-08, under 510(k) number K171648.

Who is the listed applicant for BM.IRIS?

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

What is the FDA product code for BM.IRIS?

The FDA product code for BM.IRIS is GEX. This falls under the Gastroenterology category.

Other records listing Bluecore Co., Ltd. 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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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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