Cleared Traditional

SMART BREATH RESPIRATORY COMPENSATION OPTION

K022919 · GE Medical Systems · Radiology
Sep 2002
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K022919 is an FDA 510(k) clearance for the SMART BREATH RESPIRATORY COMPENSATION OPTION, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on September 19, 2002, 15 days after receiving the submission on September 4, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K022919 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2002
Decision Date September 19, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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