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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 K001842
Device Name ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100
Applicant
SOMANETICS CORP.
1653 EAST MAPLE RD.
TROY,  MI  48083 -4208
Applicant Contact RONALD A WIDMAN
Correspondent
SOMANETICS CORP.
1653 EAST MAPLE RD.
TROY,  MI  48083 -4208
Correspondent Contact RONALD A WIDMAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/19/2000
Decision Date 09/15/2000
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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