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FDA 510(k)

SQA, SPERM QUALITY ANALYZER

K-Number: K012352 · 2001-09-21

ApplicantMedical Electronic Systems, LLC
Decision Date2001-09-21
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SQA, SPERM QUALITY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronic Systems, LLC. It received FDA 510(k) clearance on 2001-09-21 under 510(k) number K012352. 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, SPERM QUALITY ANALYZER?

SQA, SPERM QUALITY ANALYZER is a medical device that received FDA 510(k) clearance on 2001-09-21. The listed applicant is Medical Electronic Systems, LLC. The 510(k) number is K012352.

When did SQA, SPERM QUALITY ANALYZER receive FDA 510(k) clearance?

SQA, SPERM QUALITY ANALYZER received FDA 510(k) clearance on 2001-09-21, under 510(k) number K012352.

Who is the listed applicant for SQA, SPERM QUALITY ANALYZER?

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

What is the FDA product code for SQA, SPERM QUALITY ANALYZER?

The FDA product code for SQA, SPERM QUALITY ANALYZER is POV.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Electronic Systems, LLC 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.

K021746SQA V, SPERM QUALITY ANALYZER

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.

K252228Seaman Pro/SeamanCheckcells, Inc.K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.K242388LensHooke X12 PRO Semen Analysis SystemBonraybio Co., Ltd.K243114SQA-iOw Sperm Quality AnalyzerMedical Electronic Systems , Ltd.K241628YO Home Sperm TestMedical Electronic Systems , Ltd.K220828SQA-iO Sperm Quality AnalyzerMedical Electronic Systems , Ltd.

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.

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