Device Classification Name |
oximeter
|
510(k) Number |
K231531 |
Device Name |
Pediarity™ |
Applicant |
Gabi SmartCare SA |
Rue Emile Francqui 6 |
Mont-Saint-Guibert,
BE
1435
|
|
Applicant Contact |
Edouard Carton |
Correspondent |
Gabi SmartCare SA |
Rue Emile Francqui 6 |
Mont-Saint-Guibert,
BE
1435
|
|
Correspondent Contact |
Edouard Carton |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/26/2023 |
Decision Date | 12/21/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|