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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(With Arrhythmia Detection Or Alarms)
510(k) Number K221879
Device Name Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
Applicant
Caf Medical Solutions, Inc.
17539 Roberts Rd.
Hockley,  TX  77477
Applicant Contact Oscar Arriaga Yamin
Correspondent
Compliance 4 Device
118 W Prive Cr.
118 W Prive Cr.,  FL  33445
Correspondent Contact Juan Tezak
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZK   BZQ   CBQ   CBR   CBS  
CCK   CCL   DPS   DQA   DRG   DRT  
DSB   DSK   DST   DXN   FLL   MLD  
NHO   NHP   NHQ  
Date Received06/28/2022
Decision Date 08/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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