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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Semen Analysis Device
510(k) Number K021746
FOIA Releasable 510(k) K021746
Device Name SQA V, SPERM QUALITY ANALYZER
Applicant
MEDICAL ELECTRONIC SYSTEMS, LLC
269 SOUTH BEVERLY DR.
#472
BEVERLY HILLS,  CA  90212
Applicant Contact ERICA B AMMIRATI
Correspondent
MEDICAL ELECTRONIC SYSTEMS, LLC
269 SOUTH BEVERLY DR.
#472
BEVERLY HILLS,  CA  90212
Correspondent Contact ERICA B AMMIRATI
Regulation Number864.5220
Classification Product Code
POV  
Date Received05/28/2002
Decision Date 09/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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