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510(k) Data Aggregation
K Number
K021746Device Name
SQA V, SPERM QUALITY ANALYZER
Manufacturer
MEDICAL ELECTRONIC SYSTEMS, LLC
Date Cleared
2002-09-20
(115 days)
Product Code
POV, GKZ
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ELECTRONIC SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SQA V is a point-of-care, easy-to-use, electro-optical device with on-screen visualization and image freezing capabilities for semen analysis. The SQA V provides direct and calculated measurements for:
- total sperm concentration (TSC, millions/mL) .
- percent motility (%MOT) and % progressive motility (%PMOT) .
- % normal morphology (%MORPH) .
- motile sperm concentration (MSC, millions/mL) and progressive MSC (PMSC) ●
- . functional sperm concentration (FSC, millions/mL)
Device Description
The SQA V is a point-of-care, easy-to-use, electro-optical device with on-screen visualization and image freezing capabilities for semen analysis.
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K Number
K012352Device Name
SQA, SPERM QUALITY ANALYZER
Manufacturer
MEDICAL ELECTRONIC SYSTEMS, LLC
Date Cleared
2001-09-21
(58 days)
Product Code
POV, GKZ
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ELECTRONIC SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SQA is a point-of-care, easy-to-use, electro-optical device for semen analysis. The SQA provides calculated measurements for:
- total cell concentration (millions/mL) t
- . percent (%) motility
- % normal morphology .
- motile sperm concentration (MSC), (millions/mL) ●
- functional sperm concentration (FSC), (millions/mL) .
- sperm motility index (SMI) ●
Device Description
The SQA is a point-of-care, easy-to-use, electro-optical device for semen analysis.
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