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510(k) Data Aggregation
K Number
K010622Device Name
PRESSURE TRAK, MODEL 222-B
Manufacturer
SUNTECH MEDICAL INSTRUMENTS, INC.
Date Cleared
2001-03-29
(27 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SUNTECH MEDICAL INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003004Device Name
OSCAR 2, MODEL 222
Manufacturer
SUNTECH MEDICAL INSTRUMENTS, INC.
Date Cleared
2000-10-25
(30 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SUNTECH MEDICAL INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970629Device Name
TANGO NON-INVASIVE BLOOD PRESSURE MONITOR
Manufacturer
SUNTECH MEDICAL INSTRUMENTS, INC.
Date Cleared
1998-01-02
(317 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SUNTECH MEDICAL INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tango Blood Pressure Monitor is intended for use as an aid or adjunct to ECG exercise stress testing, measuring and displaying an adult patients systolic and diastolic blood pressures.
Device Description
The Tango Monitor has two operating modes, Dimensional K-Sound (DKA) and Oscillometry.
In the Oscillometric mode the Tango NIBP monitor measures:
1. Systolic Pressure (mmHg)
2. Diastolic Pressure (mmHg)
3. Pulse Rate (beats per minute)
In the Dimensional K-Sound mode (DKA) the Tango NIBP monitor measures:
1. Systolic Pressure (mmHg)
2. Diastolic Pressure (mmHg)
3. Heart Rate (beats per minute)
Depending on the mode the Monitor is in one of the following waveforms are displayed:
1. R-Wave trigger signal (DKA)
2. K-sound waveforms (DKA)
3. or Oscillometric pressure pulses (Oscillometric)
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