RAPIDPoint 500e Blood Gas System

Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

Siemens Healthcare Diagnostics, Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Rapidpoint 500e Blood Gas System.

Pre-market Notification Details

Device IDK192240
510k NumberK192240
Device Name:RAPIDPoint 500e Blood Gas System
ClassificationElectrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Applicant Siemens Healthcare Diagnostics, Inc. 2 Edgewater Drive Norwood,  MA  02062
ContactLois Parillon
CorrespondentLois Parillon
Siemens Healthcare Disgnostics, Inc. 2 Edgewater Drive Norwood,  MA  02062
Product CodeCHL  
Subsequent Product CodeCEM
Subsequent Product CodeCGA
Subsequent Product CodeCGZ
Subsequent Product CodeGKR
Subsequent Product CodeJFP
Subsequent Product CodeJGS
Subsequent Product CodeKHP
Subsequent Product CodeMQM
CFR Regulation Number862.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-19
Decision Date2020-03-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414286143 K192240 000
00630414609515 K192240 000

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