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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 K902730
Device Name SPO2 OPTION
Applicant
Protocol Systems, Inc.
14924 NW Greenbrier Pkwy.
Beaverton,  OR  97006
Applicant Contact JAMES SANDBERG
Correspondent
Protocol Systems, Inc.
14924 NW Greenbrier Pkwy.
Beaverton,  OR  97006
Correspondent Contact JAMES SANDBERG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/21/1990
Decision Date 10/22/1990
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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