Premarket Notification 510(k)

上市前通知510(k)

De Novo Classification Request

新分類申請(qǐng)

Premarket Submission Number

上市前申報(bào)編號(hào)

Intended Use

預(yù)期用途

Predicate Device

對(duì)比器械

Multiple Predicate Devices

多個(gè)對(duì)比器械

Reference Device

參考器械

Performance Data

性能數(shù)據(jù)

510(k) Summary

510(k) 摘要

510(k) Statement

510(k) 聲明

510(k) Third Party Review Program

510(k) 第三方審查計(jì)劃

General Controls

一般管制要求

Special Controls

特殊管制要求

Least Burdensome Approach

最少負(fù)擔(dān)原則

Trade Name

商品名稱

Preamendment Device

修正案前醫(yī)療器械

Postamendment Device

修正案后醫(yī)療器械

Medical Device Amendment

FDA醫(yī)療器械修正案

New Device

新型醫(yī)療器械

PMA Amendment

PMA修正案

PMA Supplement

PMA補(bǔ)充申請(qǐng)

FDA Guidance

FDA指南文件

Unclassified Device

未分類醫(yī)療器械

Interactive Review

交互式評(píng)審

FDA Cleared

FDA上市許可