Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K190213 |
Device Name |
Yikang Endotracheal Tube |
Applicant |
Jiangxi Yikang Medical Instrument Group Co., Ltd |
188 Aihua Road, Jinxian County |
Nanchang,
CN
331725
|
|
Applicant Contact |
Nicholas Su |
Correspondent |
Jiangxi Yikang Medical Instrument Group Co., Ltd |
188 Aihua Road, Jinxian County |
Nanchang,
CN
331725
|
|
Correspondent Contact |
Nicholas Su |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 02/04/2019 |
Decision Date | 09/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|