EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY

System, Thermal Regulating

SMITH MEDICAL ASD, INC.

The following data is part of a premarket notification filed by Smith Medical Asd, Inc. with the FDA for Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket, Snuggle Warm Pediatricfull Body.

Pre-market Notification Details

Device IDK141686
510k NumberK141686
Device Name:EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
ClassificationSystem, Thermal Regulating
Applicant SMITH MEDICAL ASD, INC. 1265 GREY FOX ROAD St. Paul,  MN  55112
ContactJim Johnson
CorrespondentJim Johnson
SMITH MEDICAL ASD, INC. 1265 GREY FOX ROAD St. Paul,  MN  55112
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-23
Decision Date2014-10-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10610586043819 K141686 000
30610586043325 K141686 000
30610586043332 K141686 000
30610586043349 K141686 000
30610586043356 K141686 000
30610586043363 K141686 000
30610586043387 K141686 000
30610586043394 K141686 000
30610586043400 K141686 000
30610586043417 K141686 000
30610586043424 K141686 000
30610586043431 K141686 000
30610586043448 K141686 000
30610586043455 K141686 000
30610586043479 K141686 000
15019517116175 K141686 000
30610586043370 K141686 000

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