Mistral-Air Warming Unit

System, Thermal Regulating

The Surgical Company International BV (as The 37Company)

The following data is part of a premarket notification filed by The Surgical Company International Bv (as The 37company) with the FDA for Mistral-air Warming Unit.

Pre-market Notification Details

Device IDK171234
510k NumberK171234
Device Name:Mistral-Air Warming Unit
ClassificationSystem, Thermal Regulating
Applicant The Surgical Company International BV (as The 37Company) Beeldschermweg 6F Amersfoort,  NL 3821 Ah
ContactKees Van Hassel
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedYes
Combination ProductNo
Date Received2017-04-27
Decision Date2017-05-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
ET375250PM0 K171234 000
ET37MA1200PM0 K171234 000
18719867001547 K171234 000
18719867000069 K171234 000
18719867002667 K171234 000
18719867002643 K171234 000

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