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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, breathing frequency
510(k) Number K850504
Device Name COROMETRICS 500 INFANT MONITOR
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 BARNES PARK RD., NORTH
WALLINGFORD,  CT  06492
Applicant Contact JOSEPH P LENZEN
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 BARNES PARK RD., NORTH
WALLINGFORD,  CT  06492
Correspondent Contact JOSEPH P LENZEN
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received02/08/1985
Decision Date 06/24/1985
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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