Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K201300 |
Device Name |
Airway Mobilescope |
Applicant |
Olympus Medical Systems Corp. |
2951 Ishikawa-cho |
Hachioji-Shi,
JP
192-8507
|
|
Applicant Contact |
Toshiyuki Nakajima |
Correspondent |
Olympus Corporation of the America |
3500 Corporate Parkway |
PO Box 610 |
Center Valley,
PA
18034 -0610
|
|
Correspondent Contact |
Sheri L. Musgnung |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 05/15/2020 |
Decision Date | 01/26/2021 |
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
|
Recalls |
CDRH Recalls
|
|
|