PLA

Product Code: PLA


Products Classified as PLA

967Esophageal Thermal Regulation And Gastric Suctioning DeviceEsophageal Thermal Regulation Device.

Total Product Life Cycle (TPLC) Devices

967Esophageal Thermal Regulation And Gastric Suctioning DeviceEsophageal Thermal Regulation Device.

FDA Consensus Standards

Esophageal Thermal Regulation And Gastric Suctioning Device [36728]21 CFR §870.5910 🔎
Esophageal Thermal Regulation And Gastric Suctioning Device [36709]21 CFR §870.5910 🔎
Esophageal Thermal Regulation And Gastric Suctioning Device [36708]21 CFR §870.5910 🔎

Pre-market Notifications for PLA

K180742EnsoETMAdvanced Cooling Therapy, Inc. D/b/a Attune Medical
K180244EnsoETMAdvanced Cooling Therapy, Inc. D/b/a Attune Medical
K172493EnsoETMAttune Medical
K172029EnsoETMAttune Medical
K170009Esophageal Cooling DeviceADVANCED COOLING THERAPY, LLC
K152450Esophageal Cooling DeviceADVANCED COOLING THERAPY, LLC

Global Unique Device Identification Database

20857915006160Esophageal Thermal Regulation And Gastric Suctioning Device
20857915006054Esophageal Thermal Regulation And Gastric Suctioning Device
20857915006047Esophageal Thermal Regulation And Gastric Suctioning Device
20857915006016Esophageal Thermal Regulation And Gastric Suctioning Device
20857915006009Esophageal Thermal Regulation And Gastric Suctioning Device

Maude Adverse Events

ENSOETMADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL2019-09-11
MEDI-THERM IIIGAYMAR INDUSTRIES, INC.2019-05-13
ENSOETMADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL2018-10-10
RAPR-ROUNDSTRYKER CORPORATION2018-08-28
ENSOETMADVANCED COOLING THERAPY, INC. D/B/A ATTUNE MEDICA2017-12-15
ENSOETMATTUNE MEDICAL2017-11-02
ENSOETMARTUNE MEDICAL2017-11-02
ESOPHAGEAL COOLING DEVICEADVANCED COOLING THERAPY, INC.2017-03-30
ECD (ESOPHAGEAL COOLING DEVICE)ADVANCED COOLING THERAPY2017-03-03
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