LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer

Semen Analysis Device

Bonraybio Co., Ltd.

The following data is part of a premarket notification filed by Bonraybio Co., Ltd. with the FDA for Lenshooke X1 Pro Semen Quality Analyzer, Lenshooke X1 Pro Se Semen Quality Analyzer.

Pre-market Notification Details

Device IDK202089
510k NumberK202089
Device Name:LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
ClassificationSemen Analysis Device
Applicant Bonraybio Co., Ltd. 4F., No.118, Gongye 9th Rd. Dali Dist. Taichung,  TW 41280
ContactBrown Hsu
CorrespondentFeng-yu Lee
Dynamic Biotech, Inc Dba. IVDD Regulatory Consultant 29122 Rancho Viejo Rd., Suite 212 San Juan Capistrano,  CA  92675
Product CodePOV  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-28
Decision Date2020-10-28

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