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FDA 510(k)

SQA-iOw Sperm Quality Analyzer

K-Number: K243114 · 2025-05-02

Decision Date2025-05-02
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SQA-iOw Sperm Quality Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronic Systems , Ltd.. It received FDA 510(k) clearance on 2025-05-02 under 510(k) 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. The listed applicant is Medical Electronic Systems , Ltd.. The 510(k) number is K243114.

When did SQA-iOw Sperm Quality Analyzer receive FDA 510(k) clearance?

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

Who is the listed applicant for SQA-iOw Sperm Quality Analyzer?

The FDA 510(k) record lists Medical Electronic Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Medical Electronic Systems , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: POV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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