FDA 510(k)

PrimeLOC 附著系統

K 號：K220612 · 2022-06-06

決定日期2022-06-06

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

PrimeLOC Attachment System is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Product Brands, Inc.. It received FDA 510(k) clearance on 2022-06-06 under 510(k) number K220612. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PrimeLOC Attachment System?

PrimeLOC Attachment System is a medical device that received FDA 510(k) clearance on 2022-06-06. The listed applicant is Innovative Product Brands, Inc.. The 510(k) number is K220612.

When did PrimeLOC Attachment System receive FDA 510(k) clearance?

PrimeLOC Attachment System received FDA 510(k) clearance on 2022-06-06, under 510(k) number K220612.

Who is the listed applicant for PrimeLOC Attachment System?

The FDA 510(k) record lists Innovative Product Brands, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PrimeLOC Attachment System?

The FDA product code for PrimeLOC Attachment System is NHA.

其他以 Innovative Product Brands, Inc. 為申請人之記錄

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相關器械（代碼：NHA）

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