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FDA 510(k)

SafeAir Telescopic Smoke Pencil

K-Number: K182354 · 2018-12-14

Decision Date2018-12-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Other records listing Lina Medical Aps as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.