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FDA 510(k)

Pulmonx Chartis Tablet Console

K-Number: K180011 · 2018-07-13

ApplicantPulmonx Corporation
Decision Date2018-07-13
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Pulmonx Chartis Tablet Console is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonx Corporation. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K180011. 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 Pulmonx Chartis Tablet Console?

Pulmonx Chartis Tablet Console is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Pulmonx Corporation. The 510(k) number is K180011.

When did Pulmonx Chartis Tablet Console receive FDA 510(k) clearance?

Pulmonx Chartis Tablet Console received FDA 510(k) clearance on 2018-07-13, under 510(k) number K180011.

Who is the listed applicant for Pulmonx Chartis Tablet Console?

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

What is the FDA product code for Pulmonx Chartis Tablet Console?

The FDA product code for Pulmonx Chartis Tablet Console is BZG.

Other records listing Pulmonx Corporation 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.

PMA P180002Valve, pulmonaryK253096Chartis Precision CatheterK222340Chartis Precision CatheterK212494Lung Image Analysis

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

View on FDA Database →

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

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