Cleared Traditional

MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM

K122539 · Siemens Healthcare Diagnostics · Chemistry
Apr 2013
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K122539 is an FDA 510(k) clearance for the MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Siemens Healthcare Diagnostics (Norowood, US). The FDA issued a Cleared decision on April 19, 2013, 241 days after receiving the submission on August 21, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K122539 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2012
Decision Date April 19, 2013
Days to Decision 241 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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