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 Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/21/2020 |
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
|
|
|