FDA 510(k)

Aina HbA1c 모니터링 시스템 2

K-번호: K192987 · 2020-03-26

결정일2020-03-26

제품 코드LCP

자문 위원회HE

결정Substantially Equivalent

기기 요약

Aina HbA1c Monitoring System 2 is the device name listed in this FDA 510(k) record. The listed applicant is Jana Care, Inc.. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K192987. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Aina HbA1c Monitoring System 2?

Aina HbA1c Monitoring System 2 is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Jana Care, Inc.. The 510(k) number is K192987.

When did Aina HbA1c Monitoring System 2 receive FDA 510(k) clearance?

Aina HbA1c Monitoring System 2 received FDA 510(k) clearance on 2020-03-26, under 510(k) number K192987.

Who is the listed applicant for Aina HbA1c Monitoring System 2?

The FDA 510(k) record lists Jana Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aina HbA1c Monitoring System 2?

The FDA product code for Aina HbA1c Monitoring System 2 is LCP.

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Aina HbA1c 모니터링 시스템 2

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LCP)

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