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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K862085
Device Name ARKIVE (TM)
Applicant
Diatek, Inc.
5720 Oberlin Dr.
San Diego,  CA  92121
Applicant Contact BILL MEISTER
Correspondent
Diatek, Inc.
5720 Oberlin Dr.
San Diego,  CA  92121
Correspondent Contact BILL MEISTER
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/02/1986
Decision Date 01/12/1987
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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