ATS 5000 Automatic Tourniquet Instrument

Tourniquet, Pneumatic

McEwen And Associates Consulting Ltd.

The following data is part of a premarket notification filed by Mcewen And Associates Consulting Ltd. with the FDA for Ats 5000 Automatic Tourniquet Instrument.

Pre-market Notification Details

Device IDK202919
510k NumberK202919
Device Name:ATS 5000 Automatic Tourniquet Instrument
ClassificationTourniquet, Pneumatic
Applicant McEwen And Associates Consulting Ltd. 207-1099 West 8th Avenue Vancouver,  CA V6h 1c3
ContactJulie Kerr
CorrespondentJulie Kerr
McEwen And Associates Consulting Ltd. 207-1099 West 8th Avenue Vancouver,  CA V6h 1c3
Product CodeKCY  
CFR Regulation Number878.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-05-20

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