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K Number
K013450
Device Name
NOTTA AMBULATORY RECORDER
Manufacturer
STELLATE SYSTEMS
Date Cleared
2002-01-14

(89 days)

Product Code
OLV,GWQ
Regulation Number
882.1400
Type
Abbreviated
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Notta Ambulatory Recorder is indicated for the recording and study of EEG and other physiological signals obtained during routine EEG exams, long-term monitoring in epilepsy (LTM) and sleep studies (PSG or polysomnography) either at home, at a clinical setting, or other suitable environment under physician's order.

The Notta Ambulatory Recorder is indicated for use with children and adults under the supervision of a physician or other trained health care professional. The device is intended to be worn by the patient during a recording session.

The Notta Ambulatory Recorder is not intended to be used for the monitoring of vital sigus, in critical care or intra-operative settings.

In no way are any of the device functions represented as being in and of themselves diagnostic. The system requires competent user input, and its output must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Notta Ambulatory Recorder." It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The letter primarily:

  • Confirms the device's substantial equivalence to a predicate device.
  • Outlines general regulatory requirements for marketed medical devices.
  • States the "Indications for Use" for the Notta Ambulatory Recorder (for recording EEG and other physiological signals in various settings for children and adults under physician supervision, but not for vital signs monitoring or critical care).

Therefore, I cannot provide the requested information from the provided text as it is not present in this document.

§ 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).