Device Classification Name |
Laryngoscope, Rigid
|
510(k) Number |
K191602 |
Device Name |
APA Oxy Blade |
Applicant |
Venner Medical (Singapore) Pte Ltd |
35 Joo Koon Circle |
Singapore,
SG
629110
|
|
Applicant Contact |
Adrian P. Waterton |
Correspondent |
Brauer Device Consultants, LLC |
7 Trail House Court |
Rockville,
MD
20850
|
|
Correspondent Contact |
Christine Brauer |
Regulation Number | 868.5540
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/17/2019 |
Decision Date | 08/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|