Chartis Console
FDA 510(k) K111764 · Pulmonx, Inc.
510(k) numberK111764
Submission
- Device name
- Chartis Console
- Applicant
- Pulmonx, Inc.
Redwood City, CA, US - Received
- June 23, 2011
- Decision date
- November 10, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K251777 | MESI mTABLET SPIROBZG · Traditional | Mesi D.O.O. | 03/02/2026SE |
| K241843 | TD-7301 Spirometer (TD-7301)BZG · Traditional | Gostar Co., Ltd. | 11/20/2024SE |
| K231416 | Air Next (NVD-02)BZG · Traditional | Nuvoair AB | 01/18/2024SE |
| K230501 | Spirobank OxiBZG · Traditional | Mir Medical International Research USA | 12/15/2023SE |
| K230178 | EasyOne Sky SpirometerBZG · Traditional | Ndd Medizintechnik AG | 10/19/2023SE |
| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
| K222443 | Air Smart Extra SpirometerBZG · Traditional | Feellife Health, Inc. | 08/09/2023SE |
| K213754 | SpiroHome Personal, SpiroHome ClinicBZG · Traditional | Inofab Saglik Teknolojileri A.S | 06/12/2023SE |
| K213872 | ComPAS2BZG · Traditional | Morgan Scientific, Inc. | 07/15/2022SE |
| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | Vitalograph Ireland, Ltd. | 01/26/2022SE |
More from Vitalograph Ireland, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253096 | Chartis Precision CatheterCBI · Traditional | 02/13/2026SE |
| K222340 | Chartis Precision CatheterCBI · Traditional | 12/01/2022SE |
| K212494 | Lung Image AnalysisJAK · Traditional | 09/02/2021SE |
| K180011 | Pulmonx Chartis Tablet ConsoleBZG · Traditional | 07/13/2018SE |
| K111522 | Chartis Catheter Model CHR-CA-12.0CBI · Special | 09/29/2011SE |
| K083883 | Chartis CatheterCBI · Traditional | 06/25/2009SE |
| K083199 | Chartis ConsoleBZG · Traditional | 06/25/2009SE |
| K973191 | The Visualized Endotracheal Tube System or Vett SystemBTR · Traditional | 02/13/1998SE |
Questions and answers
When was Chartis Console cleared by the FDA?
Chartis Console (K111764) received a 510(k) decision of Substantially Equivalent on November 10, 2011, 140 days after the submission was received.
What is the product code of K111764?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.