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FDA 510(k)

PeDIA

K-Number: K181424 · 2018-09-25

ApplicantPedia, LLC
Decision Date2018-09-25
Product CodeBTC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PeDIA is a medical device manufactured by Pedia, LLC. It received FDA 510(k) clearance on 2018-09-25 under approval 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. It is manufactured by Pedia, LLC. The 510(k) number is K181424.

When was PeDIA approved by the FDA?

PeDIA received FDA 510(k) clearance on 2018-09-25, under approval number K181424.

What company makes PeDIA?

PeDIA is manufactured by Pedia, LLC.

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.

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