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510(k) Data Aggregation
K Number
K991819Device Name
MAGNATEK 30
Manufacturer
MAGNA ADVANCED TECHNOLOGIES, INC.
Date Cleared
1999-08-19
(84 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
MAGNA ADVANCED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K982907Device Name
MAGNATEK 40
Manufacturer
MAGNA ADVANCED TECHNOLOGIES, INC.
Date Cleared
1998-10-02
(45 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
MAGNA ADVANCED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTEK-40 hand held pulse oximeter is used to measure the percent arterial oxygen saturation by using a completely non-invasive finger sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-40 can also measure pulse rate and pulse strength. Continuous arterial oxygen saturation monitoring is valuable in any situation where oxygen administration is indicated. Real time information allows for earlier detection of hypoxia or hyperoxia tan arterial sampling. Federal Law restricts the use of this device by or on the order of a qualified physician only.
Device Description
Hand Held Pulse Oximeter, Device Model: MTEK-40. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed.
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K Number
K983114Device Name
MAGNATEK80
Manufacturer
MAGNA ADVANCED TECHNOLOGIES, INC.
Date Cleared
1998-09-22
(18 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
MAGNA ADVANCED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MagnaTek 80 hand held CO2 Monitor (Capnometer) is intended to be used as a transportable capnometer, providing End-Tidal CO2, respiration rate, and real-time breath indications for use in clinical settings including patient transport, ICU, CCU, ER, OR, and recovery room. The Capnometer can be used for patient checking (spot checking) and data logging of End Tidal CO2 and respiration rate.
Device Description
Hand Held CO2 Monitor (Capnometer) Model: MTEK-80
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K Number
K982846Device Name
MTEK-1400
Manufacturer
MAGNA ADVANCED TECHNOLOGIES, INC.
Date Cleared
1998-09-18
(37 days)
Product Code
CCK
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
MAGNA ADVANCED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTEK-1400 unit is to be used to in order to measure CO2 concentration using the principles of infrared absorption spectrometry. This unit provides continuous non-invasive information used to aid the clinician in assessing a patient's cardiopulmonary function and metabolic state. It is extremely effective in determining the efficacy of various respiratory treatments. Capnography can aid in detecting esophageal intubations, disconnections, apnea, malignant hyperthermia and air emboli. The MTEK-1400 can also measure respiration rate and capnography. The MTEX-1400 Plus model is capable of measuring percent arterial oxygen saturation and pulse rate.
Device Description
Not Found
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K Number
K982405Device Name
MTEK-1000
Manufacturer
MAGNA ADVANCED TECHNOLOGIES, INC.
Date Cleared
1998-09-17
(69 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
MAGNA ADVANCED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTEK-1000 unit is to be used to measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity.
Device Description
The MTEK-1000 unit is a pulse oximeter. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-1000-US oximeters are equipped to monitor ECG waveforms.
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K Number
K981310Device Name
MAGNATEK C-300
Manufacturer
MAGNA ADVANCED TECHNOLOGIES, INC.
Date Cleared
1998-07-09
(90 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MAGNA ADVANCED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C-300 Coagulator is used in small surgical procedures in The dermatology, plastic surgery and general surgery in order to only coagulate (burn) an open wound or skin lesions. This device does not cut the skin, it only closes open wounds or lesions by coagulating (burning) the skin in any of the small surgical procedures mentioned above.
Device Description
Coagulator Device Name: C-300
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K Number
K981416Device Name
MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15
Manufacturer
MAGNA ADVANCED TECHNOLOGIES, INC.
Date Cleared
1998-06-24
(65 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MAGNA ADVANCED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ESU-10 / ESU-15 units is to be used in order to cut and coagulate (burn) the skin in surgical procedures.
Device Description
Electrosurgical Units, Device Model: ESU-10 / ESU-15
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