Device Classification Name |
nasopharyngoscope (flexible or rigid)
|
510(k) Number |
K181286 |
Device Name |
Ambu aScope RLS Slim |
Applicant |
Ambu A/S |
Baltorpbakken 13 |
Ballerup,
DK
2750
|
|
Applicant Contact |
Camilla Wismar |
Correspondent |
Ambu Inc. |
6230 Old Dobbin Lane, Suite 250 |
Columbia,
MD
21045
|
|
Correspondent Contact |
Sanjay Parikh |
Regulation Number | 874.4760
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/16/2018 |
Decision Date | 11/30/2018 |
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
|
|
|