Cleared Traditional

MICROBLAB, MICROLOOP

K141936 · Carefusion Germany 234 GmbH · Anesthesiology
Dec 2014
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K141936 is an FDA 510(k) clearance for the MICROBLAB, MICROLOOP, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Carefusion Germany 234 GmbH (Hoechberg, DE). The FDA issued a Cleared decision on December 29, 2014, 165 days after receiving the submission on July 17, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K141936 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2014
Decision Date December 29, 2014
Days to Decision 165 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840