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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 K802846
Device Name TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.
Applicant
THE LONDON CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
THE LONDON CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2500
Classification Product Code
KLK  
Date Received11/12/1980
Decision Date 12/17/1980
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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