Device Classification Name |
device, positive pressure breathing, intermittent
|
510(k) Number |
K213564 |
Device Name |
BiWaze Clear System |
Applicant |
ABMRC LLC |
860 Blue Gentian Road Suite 200 |
Eagan,
MN
55121
|
|
Applicant Contact |
Leah Noaeill |
Correspondent |
ABMRC LLC |
860 Blue Gentian Road Suite 200 |
Eagan,
MN
55121
|
|
Correspondent Contact |
Priyanka Paul |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 11/09/2021 |
Decision Date | 12/21/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|