Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact