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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K920966
Device Name SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)
Applicant
Aristo Medical Products, Inc.
21850 Watertown Rd.,
Bldg. D
Waukesha,  WI  53186
Applicant Contact DAVID A LOVEJOY
Correspondent
Aristo Medical Products, Inc.
21850 Watertown Rd.,
Bldg. D
Waukesha,  WI  53186
Correspondent Contact DAVID A LOVEJOY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/02/1992
Decision Date 07/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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