Cleared Special

ABL90 FLEX PLUS

K160153 · Radiometer Medical Aps · Chemistry
Nov 2016
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K160153 is an FDA 510(k) clearance for the ABL90 FLEX PLUS, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Radiometer Medical Aps (Broenshoej, DK). The FDA issued a Cleared decision on November 4, 2016, 287 days after receiving the submission on January 22, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K160153 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2016
Decision Date November 04, 2016
Days to Decision 287 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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