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FDA 510(k)

LAMIN AIR

K-Number: K080516 · 2008-06-23

ApplicantRemgenic, LLC
Decision Date2008-06-23
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LAMIN AIR is the device name listed in this FDA 510(k) record. The listed applicant is Remgenic, LLC. It received FDA 510(k) clearance on 2008-06-23 under 510(k) number K080516. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAMIN AIR?

LAMIN AIR is a medical device that received FDA 510(k) clearance on 2008-06-23. The listed applicant is Remgenic, LLC. The 510(k) number is K080516.

When did LAMIN AIR receive FDA 510(k) clearance?

LAMIN AIR received FDA 510(k) clearance on 2008-06-23, under 510(k) number K080516.

Who is the listed applicant for LAMIN AIR?

The FDA 510(k) record lists Remgenic, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAMIN AIR?

The FDA product code for LAMIN AIR is BZD.

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Related Devices (Code: BZD)

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

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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