FDA 510(k)

PerkinElmer XRpad2 4336 HWC-M 平板探测器

K号: K161966 · 2016-09-08

决定日期2016-09-08

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Perkinelmer, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K161966. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector?

PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K161966.

When did PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector receive FDA 510(k) clearance?

PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector received FDA 510(k) clearance on 2016-09-08, under 510(k) number K161966.

Who is the listed applicant for PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector?

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

What is the FDA product code for PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector?

The FDA product code for PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector is MQB.

列明Perkinelmer, Inc.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。

K203035Eonis SCID-SMA 套件 K193103NeoBase 2 非衍生物 MSMS 试剂盒 K190335GSP Neonatal Total Galactose kit K190266NeoLSD MSMS 试剂盒 K161942PerkinElmer, XRpad2 3025 HWC-M 平板探测器

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。