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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated external defibrillators (non-wearable)
510(k) Number K010207
Device Name PORTABLE INSTENSIVE CARE UNIT
Applicant
MEDICAL RESEARCH LABORATORIES, INC.
1000 ASBURY DR. NO.17
BUFFALO GROVE,  IL  60089
Applicant Contact JOEL ORLINSKY
Correspondent
MEDICAL RESEARCH LABORATORIES, INC.
1000 ASBURY DR. NO.17
BUFFALO GROVE,  IL  60089
Correspondent Contact JOEL ORLINSKY
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
LDD   MWI  
Date Received01/23/2001
Decision Date 06/14/2001
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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