FDA 510(k)

1.5T 엔도레ctal 코일, 3.0T 엔도레ctal 코일, ER 코일 지지대

K-번호: K191539 · 2020-01-31

결정일2020-01-31

제품 코드MOS

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Biomedical GmbH. It received FDA 510(k) clearance on 2020-01-31 under 510(k) number K191539. 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 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is a medical device that received FDA 510(k) clearance on 2020-01-31. The listed applicant is Rapid Biomedical GmbH. The 510(k) number is K191539.

When did 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support receive FDA 510(k) clearance?

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support received FDA 510(k) clearance on 2020-01-31, under 510(k) number K191539.

Who is the listed applicant for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

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

What is the FDA product code for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support?

The FDA product code for 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support is MOS.

Rapid Biomedical GmbH를 신청인으로 등재한 기타 기록

K21348031P/1H 머리 코일, 23Na/1H 머리 코일, 13C/1H 머리 코일 K1819481.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil K163661P-140-플렉스 코일, Na-140-플렉스 코일, C-140-플렉스 코일

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