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FDA 510(k)

太陽風暴、太陽波、Sunco以及ESB（Avalon、Galaxy、Grande、Oasis、Elite和Leisure Select）

K 號：K180576 · 2018-04-19

申請人Lpi, Inc.
決定日期2018-04-19
產品代碼LEJ
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) is the device name listed in this FDA 510(k) record. The listed applicant is Lpi, Inc.. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K180576. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)?

Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Lpi, Inc.. The 510(k) number is K180576.

When did Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) receive FDA 510(k) clearance?

Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) received FDA 510(k) clearance on 2018-04-19, under 510(k) number K180576.

Who is the listed applicant for Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)?

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

What is the FDA product code for Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)?

The FDA product code for Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) is LEJ.

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