Hillrom Heart And Respiration Rate Monitoring System Powered By EarlySense

Monitor, Breathing Frequency

Baxter Healthcare Corproration

The following data is part of a premarket notification filed by Baxter Healthcare Corproration with the FDA for Hillrom Heart And Respiration Rate Monitoring System Powered By Earlysense.

Pre-market Notification Details

Device IDK223246
510k NumberK223246
Device Name:Hillrom Heart And Respiration Rate Monitoring System Powered By EarlySense
ClassificationMonitor, Breathing Frequency
Applicant Baxter Healthcare Corproration 1069 State Route 46 East Batesville,  IN  47006
ContactJigar Shah
CorrespondentJigar Shah
Baxter Healthcare Corproration 1069 State Route 46 East Batesville,  IN  47006
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-10-20
Decision Date2022-11-18

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