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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 K811836
Device Name PO-200 BLOOD OXYGEN MONITOR
Applicant
SUMITOMO ELECTRIC INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SUMITOMO ELECTRIC INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.2500
Classification Product Code
KLK  
Date Received06/30/1981
Decision Date 07/27/1981
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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