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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K862747
Device Name 8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS
Applicant
Atlas Researches , Ltd.
P.O.B. 271
Hod-Hasharon 45102
Israel,  IL
Applicant Contact ATLAS
Correspondent
Atlas Researches , Ltd.
P.O.B. 271
Hod-Hasharon 45102
Israel,  IL
Correspondent Contact ATLAS
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/21/1986
Decision Date 08/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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