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510(k) Data Aggregation
K Number
K964825Device Name
FREEDOM TRAVELLER
Manufacturer
IMPACT CASE TECHNOLOGIES, INC.
Date Cleared
1997-05-19
(168 days)
Product Code
MLW
Regulation Number
876.5630Why did this record match?
Applicant Name (Manufacturer) :
IMPACT CASE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For kidney patients who are on continuous ambulatory peritoneal dialysis. To heat the cialysate to within one degree of 98.6.(body temperature) As a preferred alternative to heating the dialysate using a commercial heating pad on microwave oven. The solution is heated in it's original packaging, The solution (dialysate) can be heated when travelling the car cigarette lighter adapter.
Device Description
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