Chartis Console G3
Chartis Console G3 (CHR-CO-100) is a Class II device made by Pulmonx Corporation, cleared under FDA 510(k) K111764 on 10 Nov 2011 and listed in FDA GUDID since 25 Mar 2016 (UDI-DI M776CHRCO100), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM776CHRCO100 | Date25 Mar 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111764 | Date10 Nov 2011 | StatusActive |
Official records
- FDA 510(k) database K111764
Across registries
- FDA 510(k) K111764 decided 10 Nov 2011 Active
- FDA GUDID UDI-DI M776CHRCO100 listed 25 Mar 2016 Listed
Timeline
- Cleared FDA 510(k) K111764
- Listed FDA GUDID M776CHRCO100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Chartis Console
- Generic name
- Diagnostic spirometer, professional
- Model / Ref / Catalog
- G3, CHR-CO-100
- Primary DI / UDI-DI
- M776CHRCO100
- 510(k) Number
- FDA product code
- BZG
- GMDN term
- Diagnostic spirometer, professional
- Device class
- Class II
- Regulation number
- 868.1840
- GUDID distribution status
- In Commercial Distribution
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