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FDA 510(k)

Positional Sleep Assessment System (PoSAS) software

K-Number: K172799 · 2018-03-09

ApplicantAdvanced Brain Monitoring
Decision Date2018-03-09
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Positional Sleep Assessment System (PoSAS) software is a medical device manufactured by Advanced Brain Monitoring. It received FDA 510(k) clearance on 2018-03-09 under approval number K172799. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Positional Sleep Assessment System (PoSAS) software?

Positional Sleep Assessment System (PoSAS) software is a medical device that received FDA 510(k) clearance on 2018-03-09. It is manufactured by Advanced Brain Monitoring. The 510(k) number is K172799.

When was Positional Sleep Assessment System (PoSAS) software approved by the FDA?

Positional Sleep Assessment System (PoSAS) software received FDA 510(k) clearance on 2018-03-09, under approval number K172799.

What company makes Positional Sleep Assessment System (PoSAS) software?

Positional Sleep Assessment System (PoSAS) software is manufactured by Advanced Brain Monitoring.

What is the FDA product code for Positional Sleep Assessment System (PoSAS) software?

The FDA product code for Positional Sleep Assessment System (PoSAS) software is MNR.

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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.

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