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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 K831744
Device Name TRANSCUTANEOUS OXYGEN MONITOR OPTION
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2500
Classification Product Code
KLK  
Date Received05/31/1983
Decision Date 07/19/1983
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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