Cleared Traditional

GAMBRO DQM 200

K990039 · Gambro Healthcare · Chemistry
Jan 2000
Decision
386d
Days
Class 2
Risk

About This 510(k) Submission

K990039 is an FDA 510(k) clearance for the GAMBRO DQM 200, a Conductivity Rate, Urea Nitrogen (Class II — Special Controls, product code LFP), submitted by Gambro Healthcare (Lakewood, US). The FDA issued a Cleared decision on January 27, 2000, 386 days after receiving the submission on January 6, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K990039 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1999
Decision Date January 27, 2000
Days to Decision 386 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LFP — Conductivity Rate, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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