EVA15 insufflator
K-Number: K232902 · 2024-05-02
ApplicantPalliare , Ltd.
Decision Date2024-05-02
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
EVA15 insufflator is a medical device manufactured by Palliare , Ltd.. It received FDA 510(k) clearance on 2024-05-02 under approval number K232902. 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 insufflator?
EVA15 insufflator is a medical device that received FDA 510(k) clearance on 2024-05-02. It is manufactured by Palliare , Ltd.. The 510(k) number is K232902.
When was EVA15 insufflator approved by the FDA?
EVA15 insufflator received FDA 510(k) clearance on 2024-05-02, under approval number K232902.
What company makes EVA15 insufflator?
EVA15 insufflator is manufactured by Palliare , Ltd..
What is the FDA product code for EVA15 insufflator?
The FDA product code for EVA15 insufflator is HIF.
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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.