Cleared Traditional

EasyStat 300

K211559 · Medica Corporation · Chemistry
Jan 2023
Decision
617d
Days
Class 2
Risk

About This 510(k) Submission

K211559 is an FDA 510(k) clearance for the EasyStat 300, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Medica Corporation (Bedford, US). The FDA issued a Cleared decision on January 27, 2023, 617 days after receiving the submission on May 20, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K211559 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2021
Decision Date January 27, 2023
Days to Decision 617 days
Submission Type Traditional
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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