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FDA 510(k)

恆星（CON-001）

K 號：K241280 · 2024-09-12

申請人Q Bio, Inc.
決定日期2024-09-12
產品代碼QIH
諮詢委員會RA
決定相當於

器材摘要

Constellation (CON-001) is the device name listed in this FDA 510(k) record. The listed applicant is Q Bio, Inc.. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K241280. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Constellation (CON-001)?

Constellation (CON-001) is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Q Bio, Inc.. The 510(k) number is K241280.

When did Constellation (CON-001) receive FDA 510(k) clearance?

Constellation (CON-001) received FDA 510(k) clearance on 2024-09-12, under 510(k) number K241280.

Who is the listed applicant for Constellation (CON-001)?

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

What is the FDA product code for Constellation (CON-001)?

The FDA product code for Constellation (CON-001) is QIH.

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官方來源

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