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510(k) Data Aggregation
K Number
K172892Device Name
Neuro Assessment System NAS-1000
Manufacturer
Date Cleared
2018-03-08
(167 days)
Product Code
Regulation Number
870.1875Why did this record match?
Product Code :
QBE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NAS-1000 System is a medical acoustic system intended as an adjunct to standard clinical practice for use in non-invasively monitoring, detecting, recording and displaying acoustic signals in the brain. It is used for any subject undergoing a physical examination and intended only for medical assessment purposes in a clinic or hospital.
Device Description
The NAS-1000 System is a non-invasive, non-energy emitting device indicated for monitoring and recording of acoustic signals from the brain. The earbud passively receives the acoustic signal from the brain and the result is graphically displayed as an acoustic waveform on the monitor (NAS-1000M).
The NAS-1000 System consists of two components: a non-sterile, disposable, single patient use Headset (NAS-1000H) with four different sized earbuds (XS, S, M, L), and a tablet-based Monitor (NAS-1000M) which contains the software (NAS-1000S).
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