CHARTIS CONSOLE— 510(k) K083199

Substantially Equivalent

Pulmonx, Inc.

FDA 510(k) clearance K083199 for CHARTIS CONSOLE, Substantially Equivalent on 2009-06-25. Applicant: Pulmonx, Inc.. Device class: 2.

Clearance details

Applicant: Pulmonx, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2008-10-30
Decision date: 2009-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZG

K251777 — MESI mTABLET SPIRO2026-03-02
K241843 — TD-7301 Spirometer (TD-7301)2024-11-20
K231416 — Air Next (NVD-02)2024-01-18
K230501 — Spirobank Oxi2023-12-15
K230178 — EasyOne Sky Spirometer2023-10-19

More clearances from Pulmonx, Inc.

K111764 — CHARTIS CONSOLE2011-11-10
K111522 — CHARTIS CATHETER MODEL CHR-CA-12.02011-09-29
K083883 — CHARTIS CATHETER2009-06-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.