Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K190274 |
Device Name |
Endotracheal Tube |
Applicant |
Tianjin Medis Medical Device Co., Ltd. |
No. 15-A, Saida One Avenue, Xiqing Economic Development Area |
Tainjin,
CN
300385
|
|
Applicant Contact |
Yongzhi Wu |
Correspondent |
Mid-Link Consulting Co., Ltd. |
P.O. Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 02/08/2019 |
Decision Date | 07/30/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|