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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, apnea, facility use
510(k) Number K800164
Device Name 413A NEONATAL MONITOR
Applicant
XEROX CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
XEROX CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.2377
Classification Product Code
FLS  
Date Received01/25/1980
Decision Date 04/10/1980
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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