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510(k) Data Aggregation
K Number
K092858Device Name
SAFERSONIC SONOGRAPHY COVER
Manufacturer
Date Cleared
2009-11-10
(55 days)
Product Code
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
SAFERSONIC MEDIZINPRODUKTE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Safersonic® Sonography Cover is intended to be used as a sterile, single-use protective cover of an ultrasonic transducer. The Safersonic provides a sterile, microbial barrier between the transducer and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids and particulates to the patient. The Safersonic Covers are for use during procedures with sector, linear, intravaginal and rectal transducers.
Device Description
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