FDA 510(k) Applications Submitted by Erik Kulstad

FDA 510(k) Number Submission Date Device Name Applicant
K170009 01/03/2017 Esophageal Cooling Device ADVANCED COOLING THERAPY, LLC
K180244 01/29/2018 EnsoETM Advanced Cooling Therapy, Inc. d/b/a Attune Medical
K180742 03/22/2018 EnsoETM Advanced Cooling Therapy, Inc. d/b/a Attune Medical
DEN230021 03/30/2023 ensoETM Advanced Cooling Therapy, Inc. d/b/a Attune Medical
DEN140018 05/09/2014 ESOPHAGEAL COOLING DEVICE ADVANCED COOLING THERAPY, LLC
K172029 07/05/2017 EnsoETM Attune Medical
K172493 08/18/2017 EnsoETM Attune Medical
K152450 08/28/2015 Esophageal Cooling Device ADVANCED COOLING THERAPY, LLC


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