Cleared Traditional

IONOMETER EF-HK AND ACCESSORIES

K901042 · Fresenius USA, Inc. · Chemistry
Jul 1990
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K901042 is an FDA 510(k) clearance for the IONOMETER EF-HK AND ACCESSORIES, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on July 31, 1990, 147 days after receiving the submission on March 6, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K901042 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1990
Decision Date July 31, 1990
Days to Decision 147 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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