Stat Profile Prime Plus Analyzer System

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

Nova Biomedical Corporation

The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Stat Profile Prime Plus Analyzer System.

Pre-market Notification Details

Device IDK193246
510k NumberK193246
Device Name:Stat Profile Prime Plus Analyzer System
ClassificationElectrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Applicant Nova Biomedical Corporation 200 Prospect Street Waltham,  MA  02454
ContactRachel Gilbert
CorrespondentRachel Gilbert
Nova Biomedical Corporation 200 Prospect Street Waltham,  MA  02454
Product CodeCHL  
CFR Regulation Number862.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyClinical Chemistry
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-25
Decision Date2020-01-24

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