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510(k) Data Aggregation
K Number
K071661Device Name
ALPHAONE BIOFEEDBACK SYSTEM
Manufacturer
Date Cleared
2007-09-05
(78 days)
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
TELEDIAGNOSTIC SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AlphaOne EEG biofeedback system is intended for use in relaxation training. In applications for relaxation training, the AlphaOne system provides visual and/or auditory signals that correlate with changes in EEG activity useful for achieving a state of relaxation. This device does not provide alarms and does not provide automated diagnostic analysis of EEG data.
Device Description
AlphaOne EEG Biofeedback System
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K Number
K022249Device Name
NIGHTRON POLYSOMNOGRAPHY SYSTEM
Manufacturer
Date Cleared
2002-12-31
(172 days)
Product Code
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
TELEDIAGNOSTIC SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This is a diagnostic device for use upon the order of a physician and under the supervision of qualified health care professional. The device is used in the assessment of sleep related disorders by recording a range of physiologic parameters during sleep. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. This device does not provide alarms, is not intended for use as an automated apnea monitor, and does not provide automated diagnostic analysis.
Device Description
Nightron Polysomnography System
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K Number
K970659Device Name
DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
Manufacturer
Date Cleared
1997-05-16
(84 days)
Product Code
Regulation Number
882.1855Why did this record match?
Applicant Name (Manufacturer) :
TELEDIAGNOSTIC SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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