Device Classification Name |
Bronchoscope Accessory
|
510(k) Number |
K211894 |
Device Name |
Trachealator |
Applicant |
DISA Medinotec |
Stand 171, Northlands Business Park, Bush Telegraph Street |
Northriding |
Johannesburg,
ZA
2169
|
|
Applicant Contact |
Michelle Nieuwoudt |
Correspondent |
Biologics Consulting Group, Inc. |
1555 King Street, Suite 300 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Matthew Krueger |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 06/21/2021 |
Decision Date | 11/24/2021 |
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
|
|
|