Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K083199 |
Device Name |
CHARTIS CONSOLE |
Applicant |
PULMONX, INC. |
1047 ELWELL COURT |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
SUZON LOMMEL |
Correspondent |
PULMONX, INC. |
1047 ELWELL COURT |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
SUZON LOMMEL |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 10/30/2008 |
Decision Date | 06/25/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|