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FDA 510(k)

EVA15

K-Number: K202799 · 2020-10-21

ApplicantPalliare , Ltd.
Decision Date2020-10-21
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EVA15 is a medical device manufactured by Palliare , Ltd.. It received FDA 510(k) clearance on 2020-10-21 under approval number K202799. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVA15?

EVA15 is a medical device that received FDA 510(k) clearance on 2020-10-21. It is manufactured by Palliare , Ltd.. The 510(k) number is K202799.

When was EVA15 approved by the FDA?

EVA15 received FDA 510(k) clearance on 2020-10-21, under approval number K202799.

What company makes EVA15?

EVA15 is manufactured by Palliare , Ltd..

What is the FDA product code for EVA15?

The FDA product code for EVA15 is HIF.

Other Devices by Palliare , Ltd.

K193520EVA 15 Insufflator K202922END 200 Endoscopic Tubeset K230474EVA5 Insufflator K222901EVA15 insufflator K232902EVA15 insufflator

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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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