FDA 510(k)

真功能可调赫斯特矫正器

K号: K170578 · 2017-11-24

决定日期2017-11-24

产品代码LRK

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决定实质等同

器械摘要

True Function Adjustable Herbst Appliances is the device name listed in this FDA 510(k) record. The listed applicant is True Function Laboratory, Inc.. It received FDA 510(k) clearance on 2017-11-24 under 510(k) number K170578. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the True Function Adjustable Herbst Appliances?

True Function Adjustable Herbst Appliances is a medical device that received FDA 510(k) clearance on 2017-11-24. The listed applicant is True Function Laboratory, Inc.. The 510(k) number is K170578.

When did True Function Adjustable Herbst Appliances receive FDA 510(k) clearance?

True Function Adjustable Herbst Appliances received FDA 510(k) clearance on 2017-11-24, under 510(k) number K170578.

Who is the listed applicant for True Function Adjustable Herbst Appliances?

The FDA 510(k) record lists True Function Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for True Function Adjustable Herbst Appliances?

The FDA product code for True Function Adjustable Herbst Appliances is LRK.

列明True Function Laboratory, Inc.为申报人的其他记录

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