Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K141366 |
Device Name |
VIDEO BRONCHOSCOPE SYSTEM |
Applicant |
SCHOLLY FIBEROPTIC GMBH |
ROBERT-BOSCH-STR. 1-3 |
DENZLINGEN,
DE
D-79211
|
|
Applicant Contact |
SANDRA BAUMANN |
Correspondent |
SCHOLLY FIBEROPTIC GMBH |
ROBERT-BOSCH-STR. 1-3 |
DENZLINGEN,
DE
D-79211
|
|
Correspondent Contact |
SANDRA BAUMANN |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 05/23/2014 |
Decision Date | 12/17/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|