Epoc Blood Analysis System

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

Epocal Inc.

The following data is part of a premarket notification filed by Epocal Inc. with the FDA for Epoc Blood Analysis System.

Pre-market Notification Details

Device IDK200107
510k NumberK200107
Device Name:Epoc Blood Analysis System
ClassificationElectrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Applicant Epocal Inc. 2060 Walkley Road Ottawa,  CA K1g 3p5
ContactAmanda Barriage
CorrespondentAmy Goldberg
Epocal Inc. 2060 Walkley Road Ottawa,  CA K1g 3p5
Product CodeCHL  
Subsequent Product CodeCDS
Subsequent Product CodeCEM
Subsequent Product CodeCGA
Subsequent Product CodeCGL
Subsequent Product CodeCGZ
Subsequent Product CodeJFL
Subsequent Product CodeJFP
Subsequent Product CodeJGS
Subsequent Product CodeJPI
Subsequent Product CodeKHP
CFR Regulation Number862.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-17
Decision Date2020-06-05

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