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FDA 510(k)

PeriFlux6000

K-Number: K152930 · 2016-05-05

ApplicantPerimed AB
Decision Date2016-05-05
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PeriFlux6000 is a medical device manufactured by Perimed AB. It received FDA 510(k) clearance on 2016-05-05 under approval number K152930. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PeriFlux6000?

PeriFlux6000 is a medical device that received FDA 510(k) clearance on 2016-05-05. It is manufactured by Perimed AB. The 510(k) number is K152930.

When was PeriFlux6000 approved by the FDA?

PeriFlux6000 received FDA 510(k) clearance on 2016-05-05, under approval number K152930.

What company makes PeriFlux6000?

PeriFlux6000 is manufactured by Perimed AB.

What is the FDA product code for PeriFlux6000?

The FDA product code for PeriFlux6000 is DPW.

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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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