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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K974034
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 Number870.5550
Classification Product Code
DRO  
Date Received10/23/1997
Decision Date 03/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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