FDA 510(k)

AXON IR 热燈

K 號：K171087 · 2017-07-07

決定日期2017-07-07

產品代碼ILY

諮詢委員會PM

決定相當於

器材摘要

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

常見問題

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. The listed applicant is Crystal Medtech, LLC. The 510(k) number is K171087.

When did AXON IR Heat Lamp receive FDA 510(k) clearance?

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

Who is the listed applicant for AXON IR Heat Lamp?

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

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

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

相關器械（代碼：ILY）

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