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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 K170798
Device Name Dictum Health
Applicant
Dictum Health, Inc.
255 3rd Ave. Suite 102
Oakland,  CA  94607
Applicant Contact Paul Landesman
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
BZG   DPS   DQA   DQD   DRX  
DXN   DXQ   EWO   FLL  
Date Received03/17/2017
Decision Date 07/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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