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510(k) K240700

Device
HomeSleepTest (HST, HST REM+)
Applicant
Somnomedics GmbH
510(k) number
K240700
Product code
OLV
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-08
Date received
2024-03-14
Regulation
882.1400
Classification name
Standard Polysomnograph With Electroencephalograph
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Cherita James
Address
Am Sonnenstuhl 63 Randersacker DE 97236 97236

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K173690Grass TWinNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-03-09
K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO2017-12-19
K172711Comet-PLUSNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2017-11-03
K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc.2017-01-19
K142774Polysmith Sleep SystemNeurotronics, Inc.2015-02-18
K131415LIVE VIEW PANEL (LVP)Neurotronics, Inc.2013-08-09
K111055GALAXY SYSTEM; JUPITERPersonal Health Institute International2011-12-21