Device Classification Name |
system, monitoring, perinatal
|
510(k) Number |
K222327 |
Device Name |
Bloomlife MFM-Pro |
Applicant |
Bloom Technologies NV |
Schiepse Bos 6 |
Genk,
BE
3600
|
|
Applicant Contact |
Roberto Cunha |
Correspondent |
Bloomlife, Inc. |
181 2nd Street |
San Francisco,
CA
94105
|
|
Correspondent Contact |
Roberto Cunha |
Regulation Number | 884.2740
|
Classification Product Code |
|
Date Received | 08/02/2022 |
Decision Date | 02/13/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|