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Found 3 results
510(k) Data Aggregation
K Number
K051278Device Name
GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
Manufacturer
RG ENT., INC.
Date Cleared
2006-06-29
(408 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
RG ENT., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Geratherm SOS-Vacutherm is a temperature-controlled electric whole body warming system intended for use in preventing or treating the effects of incidental hypothermia in adults while at the rescue scene or during transport by air or ground to a medical facility
Device Description
The Geratherm SOS-Vacutherm System is a combination product made of two primary components:
1. An electrically warmed panel. - Class II
2. A integrated vacuum mattress / stretcher - Class I (exempt from 510(k) premarket notification).
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K Number
K051097Device Name
GERATHERM SOS-RESCUE BLANKET
Manufacturer
RG ENT., INC.
Date Cleared
2006-02-24
(301 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
RG ENT., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960224Device Name
GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
Manufacturer
RG ENT., INC.
Date Cleared
1996-03-25
(68 days)
Product Code
FLK
Regulation Number
880.2920Why did this record match?
Applicant Name (Manufacturer) :
RG ENT., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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