Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K210593 |
Device Name |
Onera Sleep Test System (Onera STS) |
Applicant |
Onera B.V. |
Torenallee 42-54 |
Eindhoven,
NL
5617BD
|
|
Applicant Contact |
Ruben de Francisco Martin |
Correspondent |
Onera B.V. |
Torenallee 42-54 |
Eindhoven,
NL
5617BD
|
|
Correspondent Contact |
Ruben de Francisco Martin |
Regulation Number | 868.2375
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/01/2021 |
Decision Date | 04/06/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04446247
|
Reviewed by Third Party |
No
|
Combination Product |
No
|