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510(k) Data Aggregation
K Number
K102856Device Name
SIROCCO THERMAL REGULATING SYSTEM
Manufacturer
Date Cleared
2011-06-30
(274 days)
Product Code
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
GALMAZ BIOTECH S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Galmaz Biotech® SIROCCO™ Thermal Regulating System is intended to prevent and treat hypothermia and provide warmth to cold or shivering patients. In addition, the Galmaz Biotech® SIROCCO™ Thermal Regulating System should be used whenever conditions exist that could cause patients to become cold.
Device Description
The Sirocco™ temperature management system consists of a portable forced-air temperature management unit and a disposable forced-air blanket (various models).
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