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: <公司> 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 ............................................................................................ 3 2. Description of the device and its intended application 器械描述和预期用途 .. 3 3. Intended therapeutic and/or diagnostic indications and claims 预期治疗和/或诊断说明和要求 ............................................................................... 3 4. Context of the evaluation and choice of clinical data types 评估背景和临床数据类型的选择 ............................................................................. 3 5. Summary of the clinical data and appraisal 总结临床数据和评价 .................... 4 6. Data analysis 数据分析 ........................................................................................ 5 6.1. Performance 性能 ................................................................................................ 5 6.2. Safety 安全 ........................................................................................................... 5 6.3. Product Literature and Instructions for Use 产品文献和使用说明 .................... 5 7. Conclusions 结论................................................................................................................................................ 6 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 ...
