Philips Biosensor BX100

Transmitters And Receivers, Physiological Signal, Radiofrequency

Philips Medical Systems

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Biosensor Bx100.

Pre-market Notification Details

Device IDK192875
510k NumberK192875
Device Name:Philips Biosensor BX100
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant Philips Medical Systems 2 Canal Park Cambridge,  MA  02141
ContactSuzanne Goodman
CorrespondentSuzanne Goodman
Philips Medical Systems 2 Canal Park Cambridge,  MA  02141
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-08
Decision Date2020-04-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.