FDA 510(k)

Mistral-Air® Warming System

K-번호: K261437 · 2026-08-07

신청자The Surgical Company International B.V., doing business as TSC Life

결정일2026-08-07

제품 코드DWJ

자문 위원회CV

결정Substantially Equivalent

기기 요약

Mistral-Air® Warming System is the device name listed in this FDA 510(k) record. The listed applicant is The Surgical Company International B.V., doing business as TSC Life. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K261437. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Mistral-Air® Warming System?

Mistral-Air® Warming System is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is The Surgical Company International B.V., doing business as TSC Life. The 510(k) number is K261437.

When did Mistral-Air® Warming System receive FDA 510(k) clearance?

Mistral-Air® Warming System received FDA 510(k) clearance on 2026-08-07, under 510(k) number K261437.

Who is the listed applicant for Mistral-Air® Warming System?

The FDA 510(k) record lists The Surgical Company International B.V., doing business as TSC Life as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mistral-Air® Warming System?

The FDA product code for Mistral-Air® Warming System is DWJ.

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Mistral-Air® Warming System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: DWJ)

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