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FDA 510(k)

BinkieRT

K-Number: K231852 · 2023-11-15

ApplicantPapricalab
Decision Date2023-11-15
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BinkieRT is a medical device manufactured by Papricalab. It received FDA 510(k) clearance on 2023-11-15 under approval number K231852. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BinkieRT?

BinkieRT is a medical device that received FDA 510(k) clearance on 2023-11-15. It is manufactured by Papricalab. The 510(k) number is K231852.

When was BinkieRT approved by the FDA?

BinkieRT received FDA 510(k) clearance on 2023-11-15, under approval number K231852.

What company makes BinkieRT?

BinkieRT is manufactured by Papricalab.

What is the FDA product code for BinkieRT?

The FDA product code for BinkieRT is IYE.

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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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