iCertainty
K-Number: K181269 · 2018-12-14
ApplicantRfpi
Decision Date2018-12-14
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
iCertainty is the device name listed in this FDA 510(k) record. The listed applicant is Rfpi. It received FDA 510(k) clearance on 2018-12-14 under 510(k) 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. The listed applicant is Rfpi. The 510(k) number is K181269.
When did iCertainty receive FDA 510(k) clearance?
iCertainty received FDA 510(k) clearance on 2018-12-14, under 510(k) number K181269.
Who is the listed applicant for iCertainty?
The FDA 510(k) record lists Rfpi as the applicant. This does not by itself establish the device manufacturer.
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.