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FDA 510(k)

SAFEAIR SMOKE PENCIL,

K-Number: K120454 · 2012-12-07

ApplicantLna Medical Aps
Decision Date2012-12-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAFEAIR SMOKE PENCIL, is the device name listed in this FDA 510(k) record. The listed applicant is Lna Medical Aps. It received FDA 510(k) clearance on 2012-12-07 under 510(k) number K120454. 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 SMOKE PENCIL,?

SAFEAIR SMOKE PENCIL, is a medical device that received FDA 510(k) clearance on 2012-12-07. The listed applicant is Lna Medical Aps. The 510(k) number is K120454.

When did SAFEAIR SMOKE PENCIL, receive FDA 510(k) clearance?

SAFEAIR SMOKE PENCIL, received FDA 510(k) clearance on 2012-12-07, under 510(k) number K120454.

Who is the listed applicant for SAFEAIR SMOKE PENCIL,?

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

What is the FDA product code for SAFEAIR SMOKE PENCIL,?

The FDA product code for SAFEAIR SMOKE PENCIL, is GEI.

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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