PINTLER PATIENT WARMING SYSTEM

System, Thermal Regulating

PINTLER MEDICAL

The following data is part of a premarket notification filed by Pintler Medical with the FDA for Pintler Patient Warming System.

Pre-market Notification Details

Device IDK113705
510k NumberK113705
Device Name:PINTLER PATIENT WARMING SYSTEM
ClassificationSystem, Thermal Regulating
Applicant PINTLER MEDICAL 3220 S. HANFORD STREET Seattle,  WA  98144
ContactMaribeth Macintyre-ellis
CorrespondentPaula Wilkerson
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-12-16
Decision Date2012-08-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B389PPWS0011 K113705 000

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