Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K111764 |
Device Name |
CHARTIS CONSOLE |
Applicant |
PULMONX, INC. |
700 CHESAPEAKE DRIVE |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
HANS SCHULZ |
Correspondent |
PULMONX, INC. |
700 CHESAPEAKE DRIVE |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
HANS SCHULZ |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 06/23/2011 |
Decision Date | 11/10/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|