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510(k) Data Aggregation
K Number
K101429Device Name
ECO SUPERGEL
Manufacturer
Date Cleared
2010-09-15
(117 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
CERACARTA SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ECO SUPERGEL® is a transmission gel media used with ultrasonic pulsed echo imaging systems. The gel, when applied on the defined area of the body, facilitates the use of the system, which is intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver.
Device Description
The ECO SUPERGEL is a water-soluble gel (transmission DESCRIT TYON of the I therapies involving ultrasound systems.
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