Skip to content
Scan

Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K201054

SOMNOscreen plus · Somnomedics GmbH · decided 2020-08-12 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ThermistorNGS152SOMNOmedics AGMNR OLV04250413410576
XL PLM sensor right for SOMNO HDNGS077SOMNOmedics AGMNR OLV04250413410514
Docking stationNGA112SOMNOmedics AGMNR OLV04250413410408
Activity SensorNGS170SOMNOmedics AGMNR OLV04250413410293
Adapter cable Sub-D-9 to MiniMed 90°SEWP152SOMNOmedics AGMNR OLV04250413406197
Dockingstation for SOMNO HDNGA102SOMNOmedics AGMNR OLV04250413403080
Pressure SensorSEN632SOMNOmedics AGMNR OLV04250413400423
Movement Sensor for PLMSEN621SOMNOmedics AGMNR OLV04250413400393
Shoulder belt- Size LNGA252SOMNOmedics AGMNR OLV04250413410552
XL PLM sensor left for SOMNO HDNGS076SOMNOmedics AGMNR OLV04250413410507
3-channel ECG sensorNGS100SOMNOmedics AGMNR OLV04250413410262
32-channel EEG Headbox for SOMNO HDNGS902SOMNOmedics AGMNR OLV04250413410217
Soft Silicone Finger Sensor for Pulse OximeterSEN224SOMNOmedics AGMNR OLV04250413406524
Right-angled adapterSEN213SOMNOmedics AGMNR OLV04250413406296
EDA SensorSEN515SOMNOmedics AGMNR OLV04250413400690
EEG / EOG Kombi ElectrodeSEP622SOMNOmedics AGMNR OLV04250413400591
Microphone for Snoring detectionSEN604SOMNOmedics AGMNR OLV04250413400584