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FDA 510(k)

pixium 4343RCE

K-Number: K170113 · 2017-02-09

Decision Date2017-02-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

pixium 4343RCE is a medical device manufactured by Philips Medical Systems Dmc GmbH. It received FDA 510(k) clearance on 2017-02-09 under approval number K170113. 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 pixium 4343RCE?

pixium 4343RCE is a medical device that received FDA 510(k) clearance on 2017-02-09. It is manufactured by Philips Medical Systems Dmc GmbH. The 510(k) number is K170113.

When was pixium 4343RCE approved by the FDA?

pixium 4343RCE received FDA 510(k) clearance on 2017-02-09, under approval number K170113.

What company makes pixium 4343RCE?

pixium 4343RCE is manufactured by Philips Medical Systems Dmc GmbH.

What is the FDA product code for pixium 4343RCE?

The FDA product code for pixium 4343RCE is MQB.

Other Devices by Philips Medical Systems Dmc GmbH

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Related Devices (Code: MQB)

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.