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510(k) Data Aggregation
K Number
K053063Device Name
PRO-FLOW MULTIPURPOSE CANNULA
Manufacturer
PRO-TECH SERVICES, INC.
Date Cleared
2005-12-13
(42 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
PRO-TECH SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pro-Flow MultiPurpose Cannula may be intended for use for simultaneous detection of respiratory airflow and sampling, or delivery, of gases, such as EtC02 or oxygen.
Device Description
Not Found
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K Number
K033402Device Name
PORTABLE SLEEP DATA RECORDER (PSDR)
Manufacturer
PRO-TECH SERVICES, INC.
Date Cleared
2004-06-30
(250 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
PRO-TECH SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PSDR system is a physiological recorder intended to display and to record for later playback of thoracic and abdominal respiratory effort, airflow, oxygen saturation, pulse rate, and a 0-1 volt DC signal (such as CPAP pressure) on the auxiliary input. The PSDR is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment.
Device Description
Portable Sleep Data Recorder
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K Number
K013905Device Name
MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
Manufacturer
PRO-TECH SERVICES, INC.
Date Cleared
2002-04-22
(147 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
PRO-TECH SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum-Synchrony Respiratory Effort System (modification EZ-1 System Respiratory Sensors) amplifier is intented for use with Pro-Tech G inchrony or the censure during steep directed ing, belancing, summing and an effort 5%
Device Description
Quantum-Synchrony Respiratory Effort System (modification EZ-1 System Respiratory Sensors)
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K Number
K982293Device Name
PRESSURE TRANSDUCER AIRFLOW SENSOR
Manufacturer
PRO-TECH SERVICES, INC.
Date Cleared
1998-07-13
(12 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
PRO-TECH SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pressure Transducer Airflow Sensor is intended for use in sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder. It is battery-powered, using a single patient use, disposable nasal cannula with a .2 micron hydrophobic filter that attaches to the patient and connects into the input of the Pressure Transducer Airflow Sensor. The cannula cannot be adequately cleaned for re-use. The outputs of the device provide low-level electrical signals for input to a physiological recorder (EEG, etc.),
Device Description
The Pressure Transducer Airlow Sensor is a small interface device which converts low levels of air pressure to corresponding low levels of voltage which can be recorded on any physiological recorder intended to record low-level electrical signals. There is one pressure, and one set of electrical outputs representing the electrical equivalent of the pressure. These electrical outputs are: the active or positive output and the reference or negative output. This device uses a disposable nasal cannula that attaches to the patient and connects to the pressure input. The electrical outputs connect to the corresponding AC-coupled inputs of the system's labeled INT O' : The electined outpote connels of an electrode jack box. The output jack on patient of the storing the modular 4-pin jack. Electrical connections are made with 1.5mm "safety" connectors. The device consists of a two-part plastic enclosure measuring approximately 7cm(W) x 12.5cm(L) x 2.5cm(H). The material is Oycolac ABS GSM, color light gray. It is battery-powered with one standard 9V alkaline cell. The estimated battery life is 320 hours (40 - eight hour uses), with an on-off switch provided to conserve battery life when not in use. The switch will also indicate a "battery test" that lights an LED indicating at least 8 hours of battery life remaining. Batteries can be replaced by removing the battery cover, removing the battery and inserting a new one in the orientation shown in the battery compartment of the unit.
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K Number
K972515Device Name
SENSOR AMPLIFIER
Manufacturer
PRO-TECH SERVICES, INC.
Date Cleared
1997-10-02
(91 days)
Product Code
GWL, 84G
Regulation Number
882.1835Why did this record match?
Applicant Name (Manufacturer) :
PRO-TECH SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TO PROVIDE AN AMPLIFYING INTERFACE BETWEEN PRO-TECH SENSOR OUTPUT AND CUSTOMER RECORDING EQUIPMENT IN PUT.
THE SENSOR ANPLIFIER IS TO BE USED WITH SUBTETS (CHILDRING E ADVES) WHERE THE RECORDING EQUIPMENT REQUIRES A HIGHER INPUT SIGNAL , THE DOVE IS INFENDED FOR SLOUD LABS.
Device Description
Not Found
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K Number
K960851Device Name
THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR
Manufacturer
PRO-TECH SERVICES, INC.
Date Cleared
1996-09-17
(200 days)
Product Code
BZQ
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
PRO-TECH SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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