Hang&Go PAC
K号: K161613 · 2016-12-28
广告
申请人Rand S.R.L.
决定日期2016-12-28
产品代码LGZ
咨询委员会医疗设备监管文本翻译如下:
HO
请注意,由于您没有提供具体的医疗设备监管文本内容,以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Hang&Go PAC is the device name listed in this FDA 510(k) record. The listed applicant is Rand S.R.L.. It received FDA 510(k) clearance on 2016-12-28 under 510(k) number K161613. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Hang&Go PAC?
Hang&Go PAC is a medical device that received FDA 510(k) clearance on 2016-12-28. The listed applicant is Rand S.R.L.. The 510(k) number is K161613.
When did Hang&Go PAC receive FDA 510(k) clearance?
Hang&Go PAC received FDA 510(k) clearance on 2016-12-28, under 510(k) number K161613.
Who is the listed applicant for Hang&Go PAC?
The FDA 510(k) record lists Rand S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hang&Go PAC?
The FDA product code for Hang&Go PAC is LGZ.
相关器械(代码:LGZ)
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。
K262532NORMOFLO™ 灌洗液加温套装及配件(IR-601,IR-501,IR-61,PL-61)ICU MedicalK260988°M加热系统及°M站Mequ A/SK252636Fluido Compact 系统The Surgical Company International B.V.K251733Fluido® AirGuard 系统The Surgical Company International BV (As Tsc Life)K232107°M 加温系统Mequ A/SK211618Fluido Compact 血液和液体加温系统The Surgical Company International B.V.
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