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FDA 510(k)

Airborne Phototherapy Light

K-Number: K160238 · 2016-06-14

Decision Date2016-06-14
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Airborne Phototherapy Light is a medical device manufactured by International Biomedical. It received FDA 510(k) clearance on 2016-06-14 under approval number K160238. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Airborne Phototherapy Light?

Airborne Phototherapy Light is a medical device that received FDA 510(k) clearance on 2016-06-14. It is manufactured by International Biomedical. The 510(k) number is K160238.

When was Airborne Phototherapy Light approved by the FDA?

Airborne Phototherapy Light received FDA 510(k) clearance on 2016-06-14, under approval number K160238.

What company makes Airborne Phototherapy Light?

Airborne Phototherapy Light is manufactured by International Biomedical.

What is the FDA product code for Airborne Phototherapy Light?

The FDA product code for Airborne Phototherapy Light is LBI.

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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.