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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K191266
Device Name VitalScan ANS
Applicant
Medeia, Inc.
7 W Figueroa St., Suites 300
Santa Barbara,  CA  93101
Applicant Contact Slav Danev
Correspondent
Compliance and Regulatory Services, LLC
3771 Southbrook Dr.
Dayton,  OH  45430
Correspondent Contact Daniel Lehtonen
Regulation Number870.2780
Classification Product Code
JOM  
Subsequent Product Codes
DPS   DXN  
Date Received05/10/2019
Decision Date 01/15/2020
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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