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510(k) Data Aggregation
K Number
K113705Device Name
PINTLER PATIENT WARMING SYSTEM
Manufacturer
Date Cleared
2012-08-31
(259 days)
Product Code
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
PINTLER MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pintler Patient Warming System aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol.
Device Description
The Pintler Patient Warming System a thermal regulating operating room pad, and a power control unit mounted to a standard IV pole. The operating room pad utilizes a low voltage resistant heating element , DC power and warms patients with conductive warming technology.
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