LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 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 Semen Quality Analyzer.

Pre-market Notification Details

Device IDK180343
510k NumberK180343
Device Name:LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
ClassificationSemen Analysis Device
Applicant Bonraybio Co., Ltd. 4F., No.118, Gongye 9th Rd. Dali Dist. Taichung,  TW 41280
ContactClare Huang
CorrespondentFeng-yu Lee
Dynamic Biotech Inc. Dba IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano,  CA  92675
Product CodePOV  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-07
Decision Date2018-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719874740702 K180343 000

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