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510(k) Data Aggregation
K Number
K991441Device Name
CADENCE DOPPLER ULTRASOUND SYSTEM
Manufacturer
MEDASONICS, INC.
Date Cleared
1999-12-28
(246 days)
Product Code
KNG
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
MEDASONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Using the 2.3 MHz probe: Early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, general indication of fetal well being. Using the 5.1 Mhz probe: Detection of blood flow in the peripheral vascular system of the body
Device Description
The Cadence system utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within the body. The system consists of a base unit that contains the speaker, the volume and on/off controls. The base unit is connected to a 2.3 MHz CW transducer, or to a 5.1 MHz CW transducer via a coil cord. The Cadence operates from a single 9 volt battery.
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K Number
K962796Device Name
NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM
Manufacturer
MEDASONICS, INC.
Date Cleared
1997-01-21
(187 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
MEDASONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961116Device Name
FIRST BEAT/CARDIO BEAT/CALC
Manufacturer
MEDASONICS, INC.
Date Cleared
1996-08-08
(141 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
MEDASONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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