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FDA 510(k)

BLUE SAIL INNOVATION

K-Number: K102161 · 2010-10-08

ApplicantShandong Blue Sail Innovation Co., Ltd.
Decision Date2010-10-08
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BLUE SAIL INNOVATION is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Blue Sail Innovation Co., Ltd.. It received FDA 510(k) clearance on 2010-10-08 under 510(k) number K102161. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLUE SAIL INNOVATION?

BLUE SAIL INNOVATION is a medical device that received FDA 510(k) clearance on 2010-10-08. The listed applicant is Shandong Blue Sail Innovation Co., Ltd.. The 510(k) number is K102161.

When did BLUE SAIL INNOVATION receive FDA 510(k) clearance?

BLUE SAIL INNOVATION received FDA 510(k) clearance on 2010-10-08, under 510(k) number K102161.

Who is the listed applicant for BLUE SAIL INNOVATION?

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

What is the FDA product code for BLUE SAIL INNOVATION?

The FDA product code for BLUE SAIL INNOVATION is LYZ.

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Other records listing Shandong Blue Sail Innovation Co., Ltd. as applicant

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Related Devices (Code: LYZ)

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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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