FDA 510(k)

SafeAir Telescopic Smoke Pencil

Número K: K182354 · 2018-12-14

Data da decisão2018-12-14

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SafeAir Telescopic Smoke Pencil is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182354. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SafeAir Telescopic Smoke Pencil?

SafeAir Telescopic Smoke Pencil is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Lina Medical Aps. The 510(k) number is K182354.

When did SafeAir Telescopic Smoke Pencil receive FDA 510(k) clearance?

SafeAir Telescopic Smoke Pencil received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182354.

Who is the listed applicant for SafeAir Telescopic Smoke Pencil?

The FDA 510(k) record lists Lina Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeAir Telescopic Smoke Pencil?

The FDA product code for SafeAir Telescopic Smoke Pencil is GEI.

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Outros registros que listam Lina Medical Aps como candidato(a)

K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)K223932SafeAir combi (SFR-combi-US)K221085LiNA OperaScope Needle K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module K182224SafeAir Smoke Evacuator compact K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module

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Fonte oficial

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