Cleared Special

epoc Blood Analysis System

K200107 · Epocal, Inc. · Chemistry
Jun 2020
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K200107 is an FDA 510(k) clearance for the epoc Blood Analysis System, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on June 5, 2020, 140 days after receiving the submission on January 17, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K200107 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2020
Decision Date June 05, 2020
Days to Decision 140 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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