SQA-iOw Sperm Quality Analyzer— 510(k) K243114

Substantially Equivalent

Medical Electronic Systems , Ltd.

FDA 510(k) clearance K243114 for SQA-iOw Sperm Quality Analyzer, Substantially Equivalent on 2025-05-02. Applicant: Medical Electronic Systems , Ltd..

Clearance details

Applicant: Medical Electronic Systems , Ltd.
Product code: Code POV
Advisory panel: Hematology
Date received: 2024-09-30
Decision date: 2025-05-02
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Caesarea, IL

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