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FDA 510(k)

HEBE (NP0000763)

K-Number: K241733 · 2025-04-16

ApplicantNovasonix Technology S.L.
Decision Date2025-04-16
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEBE (NP0000763) is a medical device manufactured by Novasonix Technology S.L.. It received FDA 510(k) clearance on 2025-04-16 under approval 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. It is manufactured by Novasonix Technology S.L.. The 510(k) number is K241733.

When was HEBE (NP0000763) approved by the FDA?

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

What company makes HEBE (NP0000763)?

HEBE (NP0000763) is manufactured by Novasonix Technology S.L..

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

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

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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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