Bodyport Cardiac Scale

Plethysmograph, Impedance

Bodyport Inc.

The following data is part of a premarket notification filed by Bodyport Inc. with the FDA for Bodyport Cardiac Scale.

Pre-market Notification Details

Device IDK211585
510k NumberK211585
Device Name:Bodyport Cardiac Scale
ClassificationPlethysmograph, Impedance
Applicant Bodyport Inc. 970 Folsom Street San Francisco,  CA  94107
ContactMara Korsunsky
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDSB  
CFR Regulation Number870.2770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-05-24
Decision Date2022-07-29

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.