NOVA STAT PROFILE PRIME CCS 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 Nova Stat Profile Prime Ccs Analyzer System.

Pre-market Notification Details

Device IDK131703
510k NumberK131703
Device Name:NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
ClassificationElectrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Applicant NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham,  MA  02454
ContactPaul W Mcdonald
CorrespondentPaul W Mcdonald
NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham,  MA  02454
Product CodeCHL  
Subsequent Product CodeCEM
Subsequent Product CodeCGA
Subsequent Product CodeCGZ
Subsequent Product CodeGKF
Subsequent Product CodeJFP
Subsequent Product CodeJGS
Subsequent Product CodeJIX
Subsequent Product CodeJJS
CFR Regulation Number862.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-11
Decision Date2014-03-25
Summary:summary

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