Cleared Traditional

Pulmonx Chartis Tablet Console

K180011 · Pulmonx Corporation · Anesthesiology
Jul 2018
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K180011 is an FDA 510(k) clearance for the Pulmonx Chartis Tablet Console, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Pulmonx Corporation (Redwood Citry, US). The FDA issued a Cleared decision on July 13, 2018, 192 days after receiving the submission on January 2, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K180011 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2018
Decision Date July 13, 2018
Days to Decision 192 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