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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 K852249
Device Name KONTRON VITALMON 5010 PATIENT MONITOR
Applicant
KONTRON INSTRUMENTS, INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Applicant Contact GEORGE CHO
Correspondent
KONTRON INSTRUMENTS, INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Correspondent Contact GEORGE CHO
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received05/23/1985
Decision Date 10/16/1986
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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