Cleared Traditional

BW685, BW685S

K121198 · Biegler GmbH · General Hospital
Jul 2012
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K121198 is an FDA 510(k) clearance for the BW685, BW685S, a Warmer, Thermal, Infusion Fluid (Class II — Special Controls, product code LGZ), submitted by Biegler GmbH (Bonita Springs, US). The FDA issued a Cleared decision on July 12, 2012, 84 days after receiving the submission on April 19, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K121198 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2012
Decision Date July 12, 2012
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LGZ — Warmer, Thermal, Infusion Fluid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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