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FDA 510(k)

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

K-Number: K180343 · 2018-11-16

ApplicantBonraybio Co., Ltd.
Decision Date2018-11-16
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer is a medical device manufactured by Bonraybio Co., Ltd.. It received FDA 510(k) clearance on 2018-11-16 under approval number K180343. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer?

LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Bonraybio Co., Ltd.. The 510(k) number is K180343.

When was LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer approved by the FDA?

LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer received FDA 510(k) clearance on 2018-11-16, under approval number K180343.

What company makes LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer?

LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer is manufactured by Bonraybio Co., Ltd..

What is the FDA product code for LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer?

The FDA product code for LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer is POV.

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Other Devices by Bonraybio Co., Ltd.

K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer K221810LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer K242388LensHooke X12 PRO Semen Analysis System

Related Devices (Code: POV)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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