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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 K821936
Device Name CRITIKON OXYGEN MONITOR, MODEL 8030
Applicant
CRITIKON COMPANY,LLC
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CRITIKON COMPANY,LLC
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2500
Classification Product Code
KLK  
Date Received06/29/1982
Decision Date 08/16/1982
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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