EnsoETM
Esophageal Thermal Regulation And Gastric Suctioning Device
Advanced Cooling Therapy, Inc. D/b/a Attune Medical
The following data is part of a premarket notification filed by Advanced Cooling Therapy, Inc. D/b/a Attune Medical with the FDA for Ensoetm.
Pre-market Notification Details
| Device ID | K180742 |
| 510k Number | K180742 |
| Device Name: | EnsoETM |
| Classification | Esophageal Thermal Regulation And Gastric Suctioning Device |
| Applicant | Advanced Cooling Therapy, Inc. D/b/a Attune Medical 3440 S. Dearborn St. #215-South Chicago, IL 60616 |
| Contact | Erik Kulstad |
| Correspondent | Erik Kulstad Advanced Cooling Therapy, Inc. D/b/a Attune Medical 3440 S. Dearborn St. #215-South Chicago, IL 60616 |
| Product Code | PLA |
| CFR Regulation Number | 870.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2018-05-17 |
| Summary: | summary |
Trademark Results [EnsoETM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENSOETM 87382831 5429773 Live/Registered |
ADVANCED COOLING THERAPY, INC. 2017-03-23 |
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