FDA 510(k)

Stasis Monitoring System

K-번호: K183634 · 2019-04-17

결정일2019-04-17

제품 코드MWI

자문 위원회CV

결정Substantially Equivalent

기기 요약

Stasis Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Stasis Labs, Inc.. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K183634. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Stasis Monitoring System?

Stasis Monitoring System is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Stasis Labs, Inc.. The 510(k) number is K183634.

When did Stasis Monitoring System receive FDA 510(k) clearance?

Stasis Monitoring System received FDA 510(k) clearance on 2019-04-17, under 510(k) number K183634.

Who is the listed applicant for Stasis Monitoring System?

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

What is the FDA product code for Stasis Monitoring System?

The FDA product code for Stasis Monitoring System is MWI.

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Stasis Monitoring System

기기 요약

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관련 임상시험

관련 기기 (코드: MWI)

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