Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K013111 |
Device Name |
EXHALE PROBE |
Applicant |
BRONCUS TECHNOLOGIES, INC. |
1400 NORTH SHORELINE BLVD., |
#A8 |
MOUNTAIN VIEW,
CA
94043 -1346
|
|
Applicant Contact |
TIMOTHY R WILLIAMS |
Correspondent |
TUV PRODUCT SERVICE, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 874.4680
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/18/2001 |
Decision Date | 10/01/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|