FDA 510(k)

Swift Ray 1

K-번호: K251678 · 2026-02-24

결정일2026-02-24

제품 코드QJF

자문 위원회SU

결정Substantially Equivalent

기기 요약

Swift Ray 1 is the device name listed in this FDA 510(k) record. The listed applicant is Swift Medical, Inc.. It received FDA 510(k) clearance on 2026-02-24 under 510(k) number K251678. The device is classified under product code QJF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Swift Ray 1?

Swift Ray 1 is a medical device that received FDA 510(k) clearance on 2026-02-24. The listed applicant is Swift Medical, Inc.. The 510(k) number is K251678.

When did Swift Ray 1 receive FDA 510(k) clearance?

Swift Ray 1 received FDA 510(k) clearance on 2026-02-24, under 510(k) number K251678.

Who is the listed applicant for Swift Ray 1?

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

What is the FDA product code for Swift Ray 1?

The FDA product code for Swift Ray 1 is QJF.

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Swift Ray 1

기기 요약

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관련 임상시험

관련 기기 (코드: QJF)

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