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FDA 510(k)

AXON IR Heat Lamp

K-Number: K171087 · 2017-07-07

Decision Date2017-07-07
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AXON IR Heat Lamp is a medical device manufactured by Crystal Medtech, LLC. It received FDA 510(k) clearance on 2017-07-07 under approval number K171087. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXON IR Heat Lamp?

AXON IR Heat Lamp is a medical device that received FDA 510(k) clearance on 2017-07-07. It is manufactured by Crystal Medtech, LLC. The 510(k) number is K171087.

When was AXON IR Heat Lamp approved by the FDA?

AXON IR Heat Lamp received FDA 510(k) clearance on 2017-07-07, under approval number K171087.

What company makes AXON IR Heat Lamp?

AXON IR Heat Lamp is manufactured by Crystal Medtech, LLC.

What is the FDA product code for AXON IR Heat Lamp?

The FDA product code for AXON IR Heat Lamp is ILY.

Related Devices (Code: ILY)

Official Source

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