FDA 510(k)

MC1 Plus

K-번호: K161502 · 2016-08-16

결정일2016-08-16

제품 코드IMI

자문 위원회PM

결정Substantially Equivalent

기기 요약

MC1 Plus is the device name listed in this FDA 510(k) record. The listed applicant is General Project S.R.L.. It received FDA 510(k) clearance on 2016-08-16 under 510(k) number K161502. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MC1 Plus?

MC1 Plus is a medical device that received FDA 510(k) clearance on 2016-08-16. The listed applicant is General Project S.R.L.. The 510(k) number is K161502.

When did MC1 Plus receive FDA 510(k) clearance?

MC1 Plus received FDA 510(k) clearance on 2016-08-16, under 510(k) number K161502.

Who is the listed applicant for MC1 Plus?

The FDA 510(k) record lists General Project S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MC1 Plus?

The FDA product code for MC1 Plus is IMI.

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기기 요약

자주 묻는 질문

관련 기기 (코드: IMI)

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