1NEED Pro
K号: K243472 · 2025-03-19
广告
器械摘要
1NEED Pro is the device name listed in this FDA 510(k) record. The listed applicant is Campomats S.R.L.. It received FDA 510(k) clearance on 2025-03-19 under 510(k) number K243472. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the 1NEED Pro?
1NEED Pro is a medical device that received FDA 510(k) clearance on 2025-03-19. The listed applicant is Campomats S.R.L.. The 510(k) number is K243472.
When did 1NEED Pro receive FDA 510(k) clearance?
1NEED Pro received FDA 510(k) clearance on 2025-03-19, under 510(k) number K243472.
Who is the listed applicant for 1NEED Pro?
The FDA 510(k) record lists Campomats S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 1NEED Pro?
The FDA product code for 1NEED Pro is QAI.
相关器械（代码：QAI）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K252591自动微针系统（CODE-X）Woorhi Mechatronics Co., Ltd.K253002SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc.K252752艾拉科尔系统，配备微孔技术Cytrellis Biosystems, Inc.K253153SER Pen Carain 微系统 (MP1209SP)Su-Ko Technologies, LLCK243800PRO Pen微针治疗系统（6883）Dermalogica, LLCK243143E-PEN (E-PEN)Bomtech Electronics Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告