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FDA 510(k)

SafeAir Telescopic Smoke Pencil

K-Number: K182354 · 2018-12-14

ApplicantLina Medical Aps
Decision Date2018-12-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Lina Medical Aps. The 510(k) number is K182354.

When was SafeAir Telescopic Smoke Pencil approved by the FDA?

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

What company makes SafeAir Telescopic Smoke Pencil?

SafeAir Telescopic Smoke Pencil is manufactured by Lina Medical Aps.

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

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

Other Devices by Lina Medical Aps

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

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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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