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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 K852959
Device Name PO-510 TCPO2 MONITOR
Applicant
SUMITOMO ELECTRIC INDUSTRIES, INC.
1-3 SHIMAYA 1-CHOME
KONOHANA-KU
OSAKA, 554 JAPAN,  JP
Applicant Contact KUNIHIKO TANIGUCHI
Correspondent
SUMITOMO ELECTRIC INDUSTRIES, INC.
1-3 SHIMAYA 1-CHOME
KONOHANA-KU
OSAKA, 554 JAPAN,  JP
Correspondent Contact KUNIHIKO TANIGUCHI
Regulation Number868.2500
Classification Product Code
KLK  
Date Received07/12/1985
Decision Date 11/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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