Device Classification Name |
stimulator, auditory, evoked response
|
510(k) Number |
K211147 |
Device Name |
ALGO 7i |
Applicant |
Path Medical GmbH |
Landsberger Strasse 65 |
Germering,
DE
82110
|
|
Applicant Contact |
Ing. Johann Oswald |
Correspondent |
Path Medical GmbH |
Landsberger Strasse 65 |
Germering,
DE
82110
|
|
Correspondent Contact |
Ing. Johann Oswald |
Regulation Number | 882.1900
|
Classification Product Code |
|
Date Received | 04/19/2021 |
Decision Date | 10/14/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|