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FDA 510(k)

iCertainty

K-Number: K181269 · 2018-12-14

ApplicantRfpi
Decision Date2018-12-14
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

iCertainty is a medical device manufactured by Rfpi. It received FDA 510(k) clearance on 2018-12-14 under approval number K181269. 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 iCertainty?

iCertainty is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Rfpi. The 510(k) number is K181269.

When was iCertainty approved by the FDA?

iCertainty received FDA 510(k) clearance on 2018-12-14, under approval number K181269.

What company makes iCertainty?

iCertainty is manufactured by Rfpi.

What is the FDA product code for iCertainty?

The FDA product code for iCertainty 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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