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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 K183687
Device Name LifeWindow LW8 Lite
Applicant
Digicare Biomedical Technology, Inc.
107 Commerce Rd.
Boynton Beach,  FL  33426
Applicant Contact Eduardo Miranda
Correspondent
Digicare Biomedical Technology, Inc.
107 Commerce Rd.
Boynton Beach,  FL  33426
Correspondent Contact Pedro Miranda
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
CCK   CCL   DQA   DRT   DSK  
DXN   FLL  
Date Received12/28/2018
Decision Date 09/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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