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FDA 510(k) Application Details - K223836
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K223836
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Building 12, Innovation and Entrepreneurship Service
Center, No. 9 Chuanqi west road
Xiangtan 411100 CN
Other 510(k) Applications for this Company
Contact
Du Jing
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
EOQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2022
Decision Date
05/15/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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