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FDA 510(k)

CHARTIS CONSOLE

K-Number: K111764 · 2011-11-10

ApplicantPulmonx, Inc.
Decision Date2011-11-10
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CHARTIS CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonx, Inc.. It received FDA 510(k) clearance on 2011-11-10 under 510(k) number K111764. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHARTIS CONSOLE?

CHARTIS CONSOLE is a medical device that received FDA 510(k) clearance on 2011-11-10. The listed applicant is Pulmonx, Inc.. The 510(k) number is K111764.

When did CHARTIS CONSOLE receive FDA 510(k) clearance?

CHARTIS CONSOLE received FDA 510(k) clearance on 2011-11-10, under 510(k) number K111764.

Who is the listed applicant for CHARTIS CONSOLE?

The FDA 510(k) record lists Pulmonx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHARTIS CONSOLE?

The FDA product code for CHARTIS CONSOLE is BZG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Pulmonx, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K111522CHARTIS CATHETER MODEL CHR-CA-12.0K083883CHARTIS CATHETERK083199CHARTIS CONSOLE

Related Devices (Code: BZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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