鼻氧管FDA 一类产品 备案流程
鼻氧管（CANNULA, NASAL, OXYGEN） FDA 一类产品 备案流程 及 费 用
一、确定鼻氧管（CANNULA, NASAL, OXYGEN）备案流程及事项
- Device Class、Product Code、Regulation Number、Proprietary Name、Medical Specialty的确定
- FDA 注册备案技术文件准备
- 美国邓白 氏代码申请及获取
- FDA Establishment Registration and List账号申请与获取
- FDA PIN 号码申请及获取
- FDA 工厂注册账号付费，PCN码获取
- 美国代理人甄选和确认
- FDA 公司注册和产品列名
- 美国UDI及GUDID申请
- ……
| ANESTHESIOLOGY | CBL | ABSORBENT, CARBON-DIOXIDE | I | 510(K) exempted |
| ANESTHESIOLOGY | BSF | ABSORBER, CARBON-DIOXIDE | I | 510(K) exempted |
| ANESTHESIOLOGY | BTC | BAG, RESERVOIR | I | 510(K) exempted |
| ANESTHESIOLOGY | CAT | CANNULA, NASAL, OXYGEN | I | 510(K) exempted |
| ANESTHESIOLOGY | BZB | CATHETER, NASAL, OXYGEN | I | 510(K) exempted |
| ANESTHESIOLOGY | BYN | CHAIR, POSTURE, FOR CARDIAC AND PULMONARYTREATMENT | I | 510(K) exempted |
| ANESTHESIOLOGY | BYD | CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) | I | 510(K) exempted |
| ANESTHESIOLOGY | BTB | HOOK, ETHER | I | 510(K) exempted |
| ANESTHESIOLOGY | BTP | DROPPER, ETHER | I | 510(K) exempted |
| ANESTHESIOLOGY | BYO | BOTTLE, BLOW | I | 510(K) exempted |
二、备案费 用 及备案时间
请联系深圳市思博达彭先生，136 2238 0915 微信 同号
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