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510(k) Data Aggregation
K Number
K983052Device Name
PERITRON PERINEOMETER MODEL 9300V OR 9300A
Manufacturer
CARDIO DESIGN PTY. LTD.
Date Cleared
1998-10-19
(48 days)
Product Code
HIR
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
CARDIO DESIGN PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Peritron is used in assessing the strength of pelvic floor muscles, teaching pelvic floor muscle exercises and for providing feedback during pelvic floor muscles exercises.
Device Description
The Peritron Perineometer comprises a vaginal or anal Sensor, Readout Unit and interconnecting tube. Peritron incorporates a pressure transducer and microprocessor to interpret the air pressure in the sensor and display it either numerically in cm water column pressure or as an analogue bar graph. Hand-held Peritron weighs 220 gm and is powered by a standard 9 volt battery housed in an integral, user-accessible compartment separated physically from the electronic components. All operating functions are controlled by one push-button. The case of Peritron is of injection moulded plastic.
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K Number
K945611Device Name
PERITRON
Manufacturer
CARDIO DESIGN PTY. LTD.
Date Cleared
1996-02-08
(450 days)
Product Code
HIR
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
CARDIO DESIGN PTY. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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