The following data is part of a premarket notification filed by Pulmonx, Inc. with the FDA for Chartis Console.
| Device ID | K083199 |
| 510k Number | K083199 |
| Device Name: | CHARTIS CONSOLE |
| Classification | Spirometer, Diagnostic |
| Applicant | PULMONX, INC. 1047 ELWELL COURT Palo Alto, CA 94303 |
| Contact | Suzon Lommel |
| Correspondent | Suzon Lommel PULMONX, INC. 1047 ELWELL COURT Palo Alto, CA 94303 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-30 |
| Decision Date | 2009-06-25 |