Sleep Profiler
K-Number: K153412 · 2016-03-14
ApplicantAdvanced Brain Monitoring, Inc.
Decision Date2016-03-14
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Sleep Profiler is a medical device manufactured by Advanced Brain Monitoring, Inc.. It received FDA 510(k) clearance on 2016-03-14 under approval number K153412. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sleep Profiler?
Sleep Profiler is a medical device that received FDA 510(k) clearance on 2016-03-14. It is manufactured by Advanced Brain Monitoring, Inc.. The 510(k) number is K153412.
When was Sleep Profiler approved by the FDA?
Sleep Profiler received FDA 510(k) clearance on 2016-03-14, under approval number K153412.
What company makes Sleep Profiler?
Sleep Profiler is manufactured by Advanced Brain Monitoring, Inc..
What is the FDA product code for Sleep Profiler?
The FDA product code for Sleep Profiler is OLZ.
Related Devices (Code: OLZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.