FDA 510(k)

Propeller 传感器型号 2014-R

K号: K152482 · 2016-03-04

决定日期2016-03-04

产品代码CAF

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Propeller Sensor Model 2014-R is the device name listed in this FDA 510(k) record. The listed applicant is Reciprocal Labs. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K152482. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Propeller Sensor Model 2014-R?

Propeller Sensor Model 2014-R is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Reciprocal Labs. The 510(k) number is K152482.

When did Propeller Sensor Model 2014-R receive FDA 510(k) clearance?

Propeller Sensor Model 2014-R received FDA 510(k) clearance on 2016-03-04, under 510(k) number K152482.

Who is the listed applicant for Propeller Sensor Model 2014-R?

The FDA 510(k) record lists Reciprocal Labs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Propeller Sensor Model 2014-R?

The FDA product code for Propeller Sensor Model 2014-R is CAF.

列明Reciprocal Labs为申报人的其他记录

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。

K152882Propeller 系统

相关器械（代码：CAF）

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。

K254171网状雾化器（UN204）；网状雾化器（UN205）；网状雾化器（UN209）；网状雾化器（UN210）Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE 用于 pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid带eTrack系统Pari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035便携式网状雾化器（JM821）Shenzhen Jermei Medical Device Technology Co., Ltd.K243468压缩机雾化器（NB-1100）；压缩机雾化器（NB-1101）；压缩机雾化器（NB-1102）；压缩机雾化器（NB-1103）Joytech Healthcare 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。