FDA 510(k)

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K番号: K172452 · 2018-01-11

決定日2018-01-11

製品コードOBR

決定大幅同等

医療機器の概要

Bruxor is the device name listed in this FDA 510(k) record. The listed applicant is Sleep Specialties, LLC. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K172452. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the Bruxor?

Bruxor is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Sleep Specialties, LLC. The 510(k) number is K172452.

When did Bruxor receive FDA 510(k) clearance?

Bruxor received FDA 510(k) clearance on 2018-01-11, under 510(k) number K172452.

Who is the listed applicant for Bruxor?

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

What is the FDA product code for Bruxor?

The FDA product code for Bruxor is OBR. This falls under the Orthopedic category.

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医療機器の概要

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関連機器（コード：OBR）

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