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FDA 510(k)

SQA-iOw Sperm Quality Analyzer

K-Number: K243114 · 2025-05-02

ApplicantMedical Electronic Systems , Ltd.
Decision Date2025-05-02
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SQA-iOw Sperm Quality Analyzer is a medical device manufactured by Medical Electronic Systems , Ltd.. It received FDA 510(k) clearance on 2025-05-02 under approval number K243114. 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 SQA-iOw Sperm Quality Analyzer?

SQA-iOw Sperm Quality Analyzer is a medical device that received FDA 510(k) clearance on 2025-05-02. It is manufactured by Medical Electronic Systems , Ltd.. The 510(k) number is K243114.

When was SQA-iOw Sperm Quality Analyzer approved by the FDA?

SQA-iOw Sperm Quality Analyzer received FDA 510(k) clearance on 2025-05-02, under approval number K243114.

What company makes SQA-iOw Sperm Quality Analyzer?

SQA-iOw Sperm Quality Analyzer is manufactured by Medical Electronic Systems , Ltd..

What is the FDA product code for SQA-iOw Sperm Quality Analyzer?

The FDA product code for SQA-iOw Sperm Quality Analyzer is POV.

Related Clinical Trials

NCT07605182 Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age NOT_YET_RECRUITING NCT06238570 Validation of Donor Oocytes Semi-automated Vitrification RECRUITING NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

Other Devices by Medical Electronic Systems , Ltd.

K161493YO Home Sperm Test K220828SQA-iO Sperm Quality Analyzer K241628YO Home Sperm Test

Related Devices (Code: POV)

K161493YO Home Sperm TestMedical Electronic Systems , Ltd. K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc. K172514Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc. K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerBonraybio Co., Ltd. K183602SwimCount Sperm Quality TestMotilitycount Aps K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.

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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