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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K133810
Device Name VC150 VITAL SIGNS MONITOR
Applicant
INNOKAS YHTYMA
TARJUSOJANTIE 12
KEMPELE, OULU,  FI 90440
Applicant Contact Tiina Kotipalo
Correspondent
INNOKAS YHTYMA
TARJUSOJANTIE 12
KEMPELE, OULU,  FI 90440
Correspondent Contact Tiina Kotipalo
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/16/2013
Decision Date 10/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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