FDA 510(k)

HEBE (NP0000763)

K-Number: K241733 · 2025-04-16

Decision Date2025-04-16

Product CodePBX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HEBE (NP0000763) is the device name listed in this FDA 510(k) record. The listed applicant is Novasonix Technology S.L.. It received FDA 510(k) clearance on 2025-04-16 under 510(k) number K241733. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEBE (NP0000763)?

HEBE (NP0000763) is a medical device that received FDA 510(k) clearance on 2025-04-16. The listed applicant is Novasonix Technology S.L.. The 510(k) number is K241733.

When did HEBE (NP0000763) receive FDA 510(k) clearance?

HEBE (NP0000763) received FDA 510(k) clearance on 2025-04-16, under 510(k) number K241733.

Who is the listed applicant for HEBE (NP0000763)?

The FDA 510(k) record lists Novasonix Technology S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEBE (NP0000763)?

The FDA product code for HEBE (NP0000763) is PBX.

Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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.