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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 K935922
Device Name 360 SLX ADVISORY DEFIBRILLATOR
Applicant
Medical Research Laboratories, Inc.
1000 Asbury Dr. #17
Buffalo Grove,  IL  60089
Applicant Contact DILIP MEHTA
Correspondent
Medical Research Laboratories, Inc.
1000 Asbury Dr. #17
Buffalo Grove,  IL  60089
Correspondent Contact DILIP MEHTA
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received12/13/1993
Decision Date 12/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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