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Found 4 results
510(k) Data Aggregation
K Number
K092893Device Name
TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES
Manufacturer
TYTAN MEDICAL CORP.
Date Cleared
2010-01-14
(115 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
TYTAN MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Manual Digital LCD Sphygmomanometer model A830 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures, at hospital or professional environment by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Device Description
TYTAN Automatic Aneroid Sphygmomanometer A730 and TYTAN Manual Digital LCD Sphygmomanometer A830 series use the Auscultatory method to measure the blood pressure. It needs to use the stethoscope as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systelic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
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K Number
K062238Device Name
TYTAN BLOOD PRESSURE CUFF
Manufacturer
TYTAN MEDICAL CORP.
Date Cleared
2006-09-21
(50 days)
Product Code
DXQ
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
TYTAN MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes.
Device Description
The TYTAN blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes. Each cuff will be packaged in a polyethylene bag.
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K Number
K033025Device Name
TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700
Manufacturer
TYTAN MEDICAL CORP.
Date Cleared
2003-12-10
(75 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
TYTAN MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference ranges are 3 1/2" to 5 1/4", 3 3/4" to 7 1/2", 7" to 10 3/4", 10 3/4" to 15 3/4", and 13 1/3" to 19 1/2". The patient population targets are newborn, infant, child, adult.
Device Description
The device is a noninvasive blood pressure measurement system.
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K Number
K023637Device Name
TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)
Manufacturer
TYTAN MEDICAL CORP.
Date Cleared
2003-02-26
(119 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
TYTAN MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tytan #6xy Series Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by Health Care Professional. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency.
Device Description
This electronic Stethoscope is used for the amplification of of heart, lung and other body sounds. This Stethoscope has 3 modes for selective frequency amplification & a 8-steps volume control.
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