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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 K840918
Device Name MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT
Applicant
BIOCHEM INTERNATIONAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIOCHEM INTERNATIONAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.2500
Classification Product Code
KLK  
Date Received03/01/1984
Decision Date 04/17/1984
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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