FDA 510(k)

NeuroLine Disposable Cranial Perforator with Hudson end

Número K: K213228 · 2022-06-20

RequerenteEmd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.

Data da decisão2022-06-20

Código do produtoHBF

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

NeuroLine Disposable Cranial Perforator with Hudson end is the device name listed in this FDA 510(k) record. The listed applicant is Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.. It received FDA 510(k) clearance on 2022-06-20 under 510(k) number K213228. The device is classified under product code HBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NeuroLine Disposable Cranial Perforator with Hudson end?

NeuroLine Disposable Cranial Perforator with Hudson end is a medical device that received FDA 510(k) clearance on 2022-06-20. The listed applicant is Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.. The 510(k) number is K213228.

When did NeuroLine Disposable Cranial Perforator with Hudson end receive FDA 510(k) clearance?

NeuroLine Disposable Cranial Perforator with Hudson end received FDA 510(k) clearance on 2022-06-20, under 510(k) number K213228.

Who is the listed applicant for NeuroLine Disposable Cranial Perforator with Hudson end?

The FDA 510(k) record lists Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroLine Disposable Cranial Perforator with Hudson end?

The FDA product code for NeuroLine Disposable Cranial Perforator with Hudson end is HBF.

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