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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 K861861
Device Name 515A NEO-TRAK NEONATAL MONITOR
Applicant
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Applicant Contact JOSEPH P LENZEN
Correspondent
Ge Medical Systems Information Technologies
61 Barnes Park Rd. N.
Wallingford,  CT  06492
Correspondent Contact JOSEPH P LENZEN
Regulation Number868.2500
Classification Product Code
KLK  
Date Received05/14/1986
Decision Date 07/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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