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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, oxygen, cutaneous, for infant not under gas anesthesia
510(k) Number K980287
Device Name SIEMENS SC9000/SC9015 TCP02/C02 MODULE
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Applicant Contact JACQUELINE E EMERY
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Correspondent Contact JACQUELINE E EMERY
Regulation Number868.2500
Classification Product Code
KLK  
Date Received01/26/1998
Decision Date 08/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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