FDA 510(k)

Sleep Profiler

K-번호: K153412 · 2016-03-14

결정일2016-03-14

제품 코드OLZ

자문 위원회NE

결정Substantially Equivalent

기기 요약

Sleep Profiler is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Brain Monitoring, Inc.. It received FDA 510(k) clearance on 2016-03-14 under 510(k) number K153412. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Sleep Profiler?

Sleep Profiler is a medical device that received FDA 510(k) clearance on 2016-03-14. The listed applicant is Advanced Brain Monitoring, Inc.. The 510(k) number is K153412.

When did Sleep Profiler receive FDA 510(k) clearance?

Sleep Profiler received FDA 510(k) clearance on 2016-03-14, under 510(k) number K153412.

Who is the listed applicant for Sleep Profiler?

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

What is the FDA product code for Sleep Profiler?

The FDA product code for Sleep Profiler is OLZ.

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Sleep Profiler

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OLZ)

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