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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 K872178
Device Name MODIFICATION TO ARKIVE(TM)
Applicant
DIATEK, INC.
5720 OBERLIN DR.
SAN DIEGO,  CA  92121 -1723
Applicant Contact K GREGORY,PHD
Correspondent
DIATEK, INC.
5720 OBERLIN DR.
SAN DIEGO,  CA  92121 -1723
Correspondent Contact K GREGORY,PHD
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/08/1987
Decision Date 01/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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