The following data is part of a premarket notification filed by Pulmonx Corporation with the FDA for Pulmonx Chartis Tablet Console.
| Device ID | K180011 |
| 510k Number | K180011 |
| Device Name: | Pulmonx Chartis Tablet Console |
| Classification | Spirometer, Diagnostic |
| Applicant | Pulmonx Corporation 700 Chesapeake Drive Redwood City, CA 94063 |
| Contact | Sherry Kim |
| Correspondent | Sherry Kim Pulmonx Corporation 700 Chesapeake Drive Redwood City, CA 94063 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-02 |
| Decision Date | 2018-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811907031123 | K180011 | 000 |
| 00811907031161 | K180011 | 000 |