FDA 510(k)

C-Qual M® 乳房板；Monarch® 顶部臂位器

K号: K211001 · 2021-05-20

申请人Medtec, Inc. Dba Civco Medical Solutions and Civco

决定日期2021-05-20

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc. Dba Civco Medical Solutions and Civco. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K211001. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner?

C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is Medtec, Inc. Dba Civco Medical Solutions and Civco. The 510(k) number is K211001.

When did C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner receive FDA 510(k) clearance?

C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner received FDA 510(k) clearance on 2021-05-20, under 510(k) number K211001.

Who is the listed applicant for C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner?

The FDA 510(k) record lists Medtec, Inc. Dba Civco Medical Solutions and Civco as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner?

The FDA product code for C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner is IYE.

官方来源

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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。

C-Qual M® 乳房板；Monarch® 顶部臂位器

器械摘要

常见问题

相关临床试验

相关器械（代码：IYE）

官方来源