FDA 510(k)

디아케어 7000

K-번호: K211207 · 2022-06-06

신청자Globus Sport and Health Technologies, LLC

결정일2022-06-06

제품 코드PBX

자문 위원회SU

결정Substantially Equivalent

기기 요약

Diacare 7000 is the device name listed in this FDA 510(k) record. The listed applicant is Globus Sport and Health Technologies, LLC. It received FDA 510(k) clearance on 2022-06-06 under 510(k) number K211207. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Diacare 7000?

Diacare 7000 is a medical device that received FDA 510(k) clearance on 2022-06-06. The listed applicant is Globus Sport and Health Technologies, LLC. The 510(k) number is K211207.

When did Diacare 7000 receive FDA 510(k) clearance?

Diacare 7000 received FDA 510(k) clearance on 2022-06-06, under 510(k) number K211207.

Who is the listed applicant for Diacare 7000?

The FDA 510(k) record lists Globus Sport and Health Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diacare 7000?

The FDA product code for Diacare 7000 is PBX.

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디아케어 7000

기기 요약

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관련 임상시험

관련 기기 (코드: PBX)

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