Search the Releasable 510(k) Database | 合法醫療器材資訊網

2018年2月2日—Youcansearchthereleasable510(k)databasebyPanel,510(k)number,ProductcodeorDevicename.Asearchquerywillproduceinformation ...

You can search the releasable 510(k) database[1] by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format:

Device Classification Name: Regulation Number: 510(k) Number: Device Name: Applicant: Contact: Product Code:[2] Date Received: Decision Date: Decision:[3] Classification Advisory Committee:[4] Review Advisory Committee: Summary or Statement

SUMMARY indicates that a summary of safety and effectiveness information is available from FDA

STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant

Types:

Traditional

...