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FDA 510(k)

PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector

K-Number: K161966 · 2016-09-08

ApplicantPerkinelmer, Inc.
Decision Date2016-09-08
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Perkinelmer, Inc.. The 510(k) number is K161966.

When was PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector approved by the FDA?

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

What company makes PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector?

PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector is manufactured by Perkinelmer, Inc..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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