STAT PROFILE ULTRA M ANALYZER

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

NOVA BIOMEDICAL CORP.

The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Ultra M Analyzer.

Pre-market Notification Details

Device IDK970710
510k NumberK970710
Device Name:STAT PROFILE ULTRA M ANALYZER
ClassificationElectrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Applicant NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham,  MA  02454 -9141
ContactPaul W Macdonald
CorrespondentPaul W Macdonald
NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham,  MA  02454 -9141
Product CodeCHL  
Subsequent Product CodeCDS
Subsequent Product CodeCEM
Subsequent Product CodeCFA
Subsequent Product CodeCGA
Subsequent Product CodeCGZ
Subsequent Product CodeJFP
Subsequent Product CodeJGS
Subsequent Product CodeJIX
Subsequent Product CodeJJY
Subsequent Product CodeJPI
Subsequent Product CodeJPK
Subsequent Product CodeKHP
CFR Regulation Number862.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-26
Decision Date1997-05-09

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