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K Number
K990522
Device 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
882.1400
Type
Traditional
Panel
NE
Reference & Predicate Devices
K990522
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, validation studies, sample sizes, expert qualifications, or ground truth. The document is an FDA 510(k) clearance letter for a medical device called "DigitaEEG and Sleep Acquisition System With or Without Pulse Oximetry Function", confirming its substantial equivalence to a predicate device. It discusses regulatory matters and indications for use but does not delve into the detailed technical performance or validation studies of the device.

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).