BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.

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

D.R.G. SCIENTIFIC INDUSTRIES

The following data is part of a premarket notification filed by D.r.g. Scientific Industries with the FDA for Blood Gases/ Po2, Pco2 And Blood Ph Analysis Prod..

Pre-market Notification Details

Device IDK863880
510k NumberK863880
Device Name:BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.
ClassificationElectrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Applicant D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston,  MA  02128
ContactVincent E Corsano
CorrespondentVincent E Corsano
D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston,  MA  02128
Product CodeCHL  
CFR Regulation Number862.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-06
Decision Date1986-11-24

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