FDA 510(k)

FloSure Ventilation Patch

K-번호: K150459 · 2016-01-05

결정일2016-01-05

제품 코드OMP

자문 위원회SU

결정Substantially Equivalent

기기 요약

FloSure Ventilation Patch is the device name listed in this FDA 510(k) record. The listed applicant is Simex Medizintechnik GmbH. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K150459. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the FloSure Ventilation Patch?

FloSure Ventilation Patch is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is Simex Medizintechnik GmbH. The 510(k) number is K150459.

When did FloSure Ventilation Patch receive FDA 510(k) clearance?

FloSure Ventilation Patch received FDA 510(k) clearance on 2016-01-05, under 510(k) number K150459.

Who is the listed applicant for FloSure Ventilation Patch?

The FDA 510(k) record lists Simex Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FloSure Ventilation Patch?

The FDA product code for FloSure Ventilation Patch is OMP.

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FloSure Ventilation Patch

기기 요약

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관련 임상시험

관련 기기 (코드: OMP)

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