Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SQA-iO Sperm Quality Analyzer

K-Number: K220828 · 2023-08-07

ApplicantMedical Electronic Systems , Ltd.
Decision Date2023-08-07
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SQA-iO 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 2023-08-07 under 510(k) number K220828. 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-iO Sperm Quality Analyzer?

SQA-iO Sperm Quality Analyzer is a medical device that received FDA 510(k) clearance on 2023-08-07. The listed applicant is Medical Electronic Systems , Ltd.. The 510(k) number is K220828.

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

SQA-iO Sperm Quality Analyzer received FDA 510(k) clearance on 2023-08-07, under 510(k) number K220828.

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

The FDA product code for SQA-iO 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.

K243114SQA-iOw Sperm Quality AnalyzerK241628YO Home Sperm TestK161493YO Home Sperm Test

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.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.

↑