Level 1 Convective Warmer

System, Thermal Regulating

Smiths Medical ASD, Inc.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Level 1 Convective Warmer.

Pre-market Notification Details

Device IDK181699
510k NumberK181699
Device Name:Level 1 Convective Warmer
ClassificationSystem, Thermal Regulating
Applicant Smiths Medical ASD, Inc. 6000 Nathan Lane Minneapolis,  MN  55442
ContactDonna M. Semlak
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-06-27
Decision Date2018-07-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15019517121551 K181699 000
15019517100457 K181699 000
15019517100297 K181699 000
15019517100280 K181699 000
15019517100273 K181699 000
15019517100303 K181699 000

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