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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K000712
Device Name PORTABLE INTENSIVE CARE UNIT, MODEL PIC
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 Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
LDD   MKJ   MWI  
Date Received03/02/2000
Decision Date 04/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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