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FDA 510(k)

HPR Cordless Hygiene Handpiece

K-Number: K243911 · 2024-12-20

Decision Date2024-12-20
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HPR Cordless Hygiene Handpiece is a medical device manufactured by Handpiece Headquarters. It received FDA 510(k) clearance on 2024-12-20 under approval number K243911. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HPR Cordless Hygiene Handpiece?

HPR Cordless Hygiene Handpiece is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Handpiece Headquarters. The 510(k) number is K243911.

When was HPR Cordless Hygiene Handpiece approved by the FDA?

HPR Cordless Hygiene Handpiece received FDA 510(k) clearance on 2024-12-20, under approval number K243911.

What company makes HPR Cordless Hygiene Handpiece?

HPR Cordless Hygiene Handpiece is manufactured by Handpiece Headquarters.

What is the FDA product code for HPR Cordless Hygiene Handpiece?

The FDA product code for HPR Cordless Hygiene Handpiece is EKX.

Other Devices by Handpiece Headquarters

Related Devices (Code: EKX)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.