CLINICAL EVALUATION REPORT 临床评估报告 For Product: XXXX 产品：XXXX Document No
X X X X X X X X 文件编号 Version: 1
0 版本: Date: 2013-05-17 日期: Author: 作者: Reviewed by: 审阅: Approved by: 批准: CLINICAL EVALUATION REPORT for Product XXXX 临床评估报告 产品 XXXX Docu ment No
XXXXXXXX 文件编号：XXXXXXXX Version: 1
0 版本 Date: 2013-05-17 日期 Page 页码 2 of 6 Table of Content 目录 Page 页码 1
General details 总述
Description of the device and its intended application 器械描述和预期用途
Intended therapeutic and/or diagnostic indications and claims 预期治疗和/或诊断说明和要求
Context of the evaluation and choice of clinical data types 评估背景和临床数据类型的选择
