Device Classification Name |
Device, Positive Pressure Breathing, Intermittent
|
510(k) Number |
K191912 |
Device Name |
BiWaze Cough |
Applicant |
ABMRC LLC |
239, Fair Child Street, Daniel Island |
Charleston,
SC
29492
|
|
Applicant Contact |
Chad M Boerst |
Correspondent |
ABMRC LLC |
239, Fair Child Street, Daniel Island |
Charleston,
SC
29492
|
|
Correspondent Contact |
Sneha S P |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/17/2019 |
Decision Date | 03/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|