LIFE-AIR 1000 PATIENT WARMING COVERS

System, Thermal Regulating

PROGRESSIVE DYNAMICS, INC.

The following data is part of a premarket notification filed by Progressive Dynamics, Inc. with the FDA for Life-air 1000 Patient Warming Covers.

Pre-market Notification Details

Device IDK914383
510k NumberK914383
Device Name:LIFE-AIR 1000 PATIENT WARMING COVERS
ClassificationSystem, Thermal Regulating
Applicant PROGRESSIVE DYNAMICS, INC. 507 INDUSTRIAL RD. Marshall,  MI  49068 -1796
ContactDavid Dykehouse
CorrespondentDavid Dykehouse
PROGRESSIVE DYNAMICS, INC. 507 INDUSTRIAL RD. Marshall,  MI  49068 -1796
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-01
Decision Date1992-03-30

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