Halo AF Detection System

Transmitters And Receivers, Electrocardiograph, Telephone

LIVMOR

The following data is part of a premarket notification filed by Livmor with the FDA for Halo Af Detection System.

Pre-market Notification Details

Device IDK201208
510k NumberK201208
Device Name:Halo AF Detection System
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant LIVMOR 16470 Bake Pkwy., Ste. 200 Irvine,  CA  92618
ContactKen Persen
CorrespondentKen Persen
LIVMOR 16470 Bake Pkwy., Ste. 200 Irvine,  CA  92618
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-05
Decision Date2020-09-23

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