The following data is part of a premarket notification filed by Pulmonx, Inc. with the FDA for Chartis Console.
| Device ID | K111764 |
| 510k Number | K111764 |
| Device Name: | CHARTIS CONSOLE |
| Classification | Spirometer, Diagnostic |
| Applicant | PULMONX, INC. 700 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Contact | Hans Schulz |
| Correspondent | Hans Schulz PULMONX, INC. 700 CHESAPEAKE DRIVE Redwood City, CA 94063 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-23 |
| Decision Date | 2011-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M776CHRCO100 | K111764 | 000 |