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Found 3 results
510(k) Data Aggregation
K Number
K172986Device Name
Zmachine Synergy
Manufacturer
Consolidated Research of Richmond, Inc. dba General Sleep Co
Date Cleared
2017-12-19
(83 days)
Product Code
OLV, MNR, OMC
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
Consolidated Research of Richmond, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zmachine Synergy is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.
Device Description
The Zmachine Synergy system is a portable, battery operated, medical device housed within an ABS enclosure. The system combines the single-channel EEG recording capability of the Zmachine DT-100 (K101830) with the respiratory signal recording capability of the Resmed ApneaLink Air (K143272). The Zmachine Synergy is thereby capable of recording EEG, respiratory airflow, respiratory effort, blood oxygen saturation, pulse rate, and body position during sleep.
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K Number
K142825Device Name
Zmachine
Manufacturer
CONSOLIDATED RESEARCH OF RICHMOND, INC
Date Cleared
2015-01-20
(112 days)
Product Code
OLZ, OLV, OMC
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED RESEARCH OF RICHMOND, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CRI Zmachine is a single-channel, EEG acquisition and analysis system, designed for use in the home or clinical environments. This device is intended to be used by qualified healthcare practitioners to monitor the wake and sleep states of adult patients and as an adjunct to their diagnosis of sleep disorders.
Device Description
The CRI Zmachine is a battery-operated, single-channel, EEG acquisition and analysis system. The Zmachine system includes the Zmachine device, disposable EEG sensors, sensor cable, and a wall charger. The device operates on data from the differential-mastoid EEG channel to determine the wake and sleep states (wake, light sleep, deep sleep and REM) of the patient every 30 seconds.
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K Number
K101830Device Name
ZMACHINE, MODEL DT-100
Manufacturer
CONSOLIDATED RESEARCH OF RICHMOND, INC
Date Cleared
2011-03-31
(273 days)
Product Code
OLV
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
CONSOLIDATED RESEARCH OF RICHMOND, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CRI Zmachine is a single-channel, EEG acquisition and analysis system, designed for use in the home or clinical environments. This device is intended to be used by qualified healthcare practitioners to monitor the wake and sleep states of adult patients and as an adjunct to their diagnosis of sleep disorders.
Device Description
The CRI Zmachine is a battery-operated, single-channel, EEG acquisition and analysis system. The Zmachine system includes the Zmachine device, disposable EEG sensor cable, and a wall charger. The device operates on data from the differential-mastoid EEG channel to determine the wake and sleep states of the patient every 30 seconds.
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