VitalScan ANS

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Medeia, Inc.

The following data is part of a premarket notification filed by Medeia, Inc. with the FDA for Vitalscan Ans.

Pre-market Notification Details

Device IDK191266
510k NumberK191266
Device Name:VitalScan ANS
ClassificationPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant Medeia, Inc. 7 W Figueroa Street, Suites 300 Santa Barbara,  CA  93101
ContactSlav Danev
CorrespondentDaniel Lehtonen
Compliance And Regulatory Services LLC 3771 Southbrook Dr Dayton,  OH  45430
Product CodeJOM  
Subsequent Product CodeDPS
Subsequent Product CodeDXN
CFR Regulation Number870.2780 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-10
Decision Date2020-01-15

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