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510(k) Data Aggregation
K Number
K960421Device Name
SINUSCAN 102/SINUSPRINT
Manufacturer
FERGUSON MEDICAL
Date Cleared
1997-04-16
(443 days)
Product Code
LWI
Regulation Number
892.1560Why did this record match?
Product Code :
LWI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oriola Sinuscan 102/Sinusprint device is intended for use in the ultrasound detection of frontal and maxillary sinusitis.
Device Description
The Oriola Sinuscan 102/ Sinusprint is a pulsed ultrasound scanner. The Oriola Sinuscan 102/Sinusprint device functions by ultrasonic sending pulses of energy and receiving echoes from acoustic interfaces in the manner of an echo sounder. The reflected echoes are converted to an electric signal and concise on the LCD display and/or printed by the printer.
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K Number
K960044Device Name
ULTRAMAX/MODEL NUMBER A1
Manufacturer
ENTLAB OY
Date Cleared
1996-08-02
(213 days)
Product Code
LWI
Regulation Number
892.1560Why did this record match?
Product Code :
LWI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ultramax ultrasonic diagnostic system is intended to assist the physician in the diagnosis of maxillary and frontal sinusitis by detecting fluid in the sinus cavity.
Device Description
The Ultramax is an A-scan, pulseecho device, equipped with a single unfocused flat 8 mm 3 MHz transducer. Pulse repetition rate is fixed at 300 Hz. The only controls on the device are the receiver gain, and the range that can be selected between "8" (0-8 cm), " 4 " (0-4 cm) and "4E" (4-8 cm). These selections do not effect the emitted acoustic power.
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K Number
K960241Device Name
CPR GENERAL SURGERY TRAY
Manufacturer
CUSTOM PACK RELIABILITY
Date Cleared
1996-03-22
(66 days)
Product Code
LWI
Regulation Number
892.1560Why did this record match?
Product Code :
LWI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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