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FDA 510(k) Application Details - K230280
Device Classification Name
Bronchoscope Accessory
More FDA Info for this Device
510(K) Number
K230280
Device Name
Bronchoscope Accessory
Applicant
GA Health Company Limited
Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin
Hong Kong HK
Other 510(k) Applications for this Company
Contact
Cindy Ye
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
KTI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/01/2023
Decision Date
05/11/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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