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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 K012766
Device Name PORTABLE INTENSIVE CARE UNIT
Applicant
Medical Research Laboratories, Inc.
1000 Asbury Dr. #17
Buffalo Grove,  IL  60089
Applicant Contact JOEL ORLINSKY
Correspondent
Medical Research Laboratories, Inc.
1000 Asbury Dr. #17
Buffalo Grove,  IL  60089
Correspondent Contact JOEL ORLINSKY
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
LDD  
Date Received08/17/2001
Decision Date 01/23/2002
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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