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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 K830197
Device Name TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS
Applicant
DIAMOND SHAMROCK CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DIAMOND SHAMROCK CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.2500
Classification Product Code
KLK  
Date Received01/20/1983
Decision Date 11/29/1983
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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