510(k) DEN230021

Device

ensoETM

Applicant

Advanced Cooling Therapy, Inc. D/B/A Attune Medical

510(k) number

DEN230021

Product code

QXV

Decision

Unknown (DENG)

Decision date

2023-09-13

Date received

2023-03-30

Regulation

870.5720

Classification name

Temperature Regulation Device For Esophageal Protection During Cardiac Ablation

Medical specialty

Cardiovascular

Review panel

Cardiovascular

Device class

2

Clearance type

Direct

Third party reviewed

N