Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K180011 |
Device Name |
Pulmonx Chartis Tablet Console |
Applicant |
Pulmonx Corporation |
700 Chesapeake Drive |
Redwood City,
CA
94063
|
|
Applicant Contact |
Sherry Kim |
Correspondent |
Pulmonx Corporation |
700 Chesapeake Drive |
Redwood City,
CA
94063
|
|
Correspondent Contact |
Sherry Kim |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 01/02/2018 |
Decision Date | 07/13/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|