PeDIA
K-Number: K181424 · 2018-09-25
ApplicantPedia, LLC
Decision Date2018-09-25
Product CodeBTC
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
PeDIA is the device name listed in this FDA 510(k) record. The listed applicant is Pedia, LLC. It received FDA 510(k) clearance on 2018-09-25 under 510(k) number K181424. The device is classified under product code BTC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PeDIA?
PeDIA is a medical device that received FDA 510(k) clearance on 2018-09-25. The listed applicant is Pedia, LLC. The 510(k) number is K181424.
When did PeDIA receive FDA 510(k) clearance?
PeDIA received FDA 510(k) clearance on 2018-09-25, under 510(k) number K181424.
Who is the listed applicant for PeDIA?
The FDA 510(k) record lists Pedia, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PeDIA?
The FDA product code for PeDIA is BTC.
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.