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510(k) Data Aggregation
K Number
K990522Device Name
WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
Manufacturer
LA MONT MEDICAL, INC.
Date Cleared
1999-05-19
(90 days)
Product Code
OLV, GWQ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
LA MONT MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- For long term unattended EEG or other electrophysiological sigmal monitoring and recording.
- This device is intended for use by physicians skilled in alectroencephalography. These individuals are typically Board Certified Neurologists or Neurophysiologists or the equivalent or Ph.D. level Electroencephalographers.
- We recommend placement of electrodes in accordance with the 10.20 International System.
Device Description
DigitaEEG and Sleep Acquisition System With or Without Pulse Oximetry Function
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