HEBE (NP0000763)
K号: K241733 · 2025-04-16
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决定日期2025-04-16
产品代码PBX
咨询委员会SU
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决定实质等同
器械摘要
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.
常见问题
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.
相关器械（代码：PBX）
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官方来源
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