Device Classification Name |
reprocessed bronchoscope
|
510(k) Number |
K203614 |
Device Name |
Monarch Bronchoscope |
Applicant |
Auris Health Inc., a Johnson and Johnson Family Company |
150 Shoreline Drive |
Redwood City,
CA
94065
|
|
Applicant Contact |
Somi Ekwealor |
Correspondent |
Auris Health Inc., a Johnson and Johnson Family Company |
150 Shoreline Drive |
Redwood City,
CA
94065
|
|
Correspondent Contact |
Somi Ekwealor |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 12/10/2020 |
Decision Date | 03/11/2021 |
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
|
|
|