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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K903959
Device Name NEONATAL METASCOPE
Applicant
Cybermedic, Inc.
C/O Mckenna & Cuneo Law Office
1575 Eye St., NW
Washington,  DC  20005
Applicant Contact RICHARD MANTHEI
Correspondent
Cybermedic, Inc.
C/O Mckenna & Cuneo Law Office
1575 Eye St., NW
Washington,  DC  20005
Correspondent Contact RICHARD MANTHEI
Regulation Number868.1850
Classification Product Code
BZK  
Date Received08/28/1990
Decision Date 11/23/1990
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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