FDA 510(k)

16채널 플렉스 스피더 미디어웨이트 1.5T (Q7000246); 16채널 플렉스 스피더 라지 1.5T (Q7000247)

K-번호: K244054 · 2025-02-28

결정일2025-02-28

제품 코드MOS

자문 위원회RA

결정Substantially Equivalent

기기 요약

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) is the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K244054. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)?

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Quality Electrodynamics. The 510(k) number is K244054.

When did 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) receive FDA 510(k) clearance?

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) received FDA 510(k) clearance on 2025-02-28, under 510(k) number K244054.

Who is the listed applicant for 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)?

The FDA 510(k) record lists Quality Electrodynamics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)?

The FDA product code for 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) is MOS.

Quality Electrodynamics를 신청인으로 등재한 기타 기록

K233652Contour Hand/Wrist (Q7000232)K233656Contour Shoulder

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