FDA 510(k)

6450 초음파 시스템 (MyLabE80); 6450 초음파 시스템 (MyLabE85)

K-번호: K241671 · 2025-05-16

결정일2025-05-16

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K241671. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Esaote, S.p.A.. The 510(k) number is K241671.

When did 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) receive FDA 510(k) clearance?

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) received FDA 510(k) clearance on 2025-05-16, under 510(k) number K241671.

Who is the listed applicant for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?

The FDA product code for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is IYN.

Esaote, S.p.A.를 신청인으로 등재한 기타 기록

K261331I-Genius (100019400)K2532886450 초음파 시스템 (MyLabE80); 6450 초음파 시스템 (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)K2432536600 초음파 시스템 (MyLabA50); 6600 초음파 시스템 (MyLabA70)

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관련 기기 (코드: IYN)

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