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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 K892217
Device Name CAV SAT OXIMETER MODEL 100
Applicant
Somanetics Corp.
1653 E. Maple Rd.
Troy,  MI  48083 -4208
Applicant Contact GARY D LEWIS
Correspondent
Somanetics Corp.
1653 E. Maple Rd.
Troy,  MI  48083 -4208
Correspondent Contact GARY D LEWIS
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/03/1989
Decision Date 05/18/1990
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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