Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name standard polysomnograph with electroencephalograph
510(k) Number K201054
Device Name SOMNOscreen plus
Applicant
Somnomedics GmbH
Am Sonnenstuhl 63
Randersacker,  DE 97236
Applicant Contact Stephanie Wolski
Correspondent
Somnomedics GmbH
Am Sonnenstuhl 63
Randersacker,  DE 97236
Correspondent Contact Stephanie Wolski
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
MNR  
Date Received04/21/2020
Decision Date 08/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-