Device Classification Name |
bronchoscope accessory
|
510(k) Number |
K213060 |
Device Name |
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle |
Applicant |
Micro-Tech (Nanjing) Co., Ltd. |
No. 10 Gaoke Third Road, |
Nanjing National Hi-tech Industrial Development Zone |
Nanjing,
CN
210032
|
|
Applicant Contact |
Sally He |
Correspondent |
Micro-Tech (Nanjing) Co., Ltd. |
No. 10 Gaoke Third Road, |
Nanjing National Hi-tech Industrial Development Zone |
Nanjing,
CN
210032
|
|
Correspondent Contact |
Sally He |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 09/22/2021 |
Decision Date | 07/20/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|