FDA 510(k)

Pseudo-Patient

K-번호: K180697 · 2018-07-10

결정일2018-07-10

제품 코드IYE

자문 위원회RA

결정Substantially Equivalent

기기 요약

Pseudo-Patient is the device name listed in this FDA 510(k) record. The listed applicant is Rtsafe, Inc.. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K180697. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Pseudo-Patient?

Pseudo-Patient is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is Rtsafe, Inc.. The 510(k) number is K180697.

When did Pseudo-Patient receive FDA 510(k) clearance?

Pseudo-Patient received FDA 510(k) clearance on 2018-07-10, under 510(k) number K180697.

Who is the listed applicant for Pseudo-Patient?

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

What is the FDA product code for Pseudo-Patient?

The FDA product code for Pseudo-Patient is IYE.

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Pseudo-Patient

기기 요약

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관련 임상시험

관련 기기 (코드: IYE)

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