Device Classification Name |
perineometer
|
510(k) Number |
K231780 |
Device Name |
Perifit Care+ |
Applicant |
X6 Innovations |
128 Rue De La Boétie |
Paris,
FR
75008
|
|
Applicant Contact |
Robin Reynaud |
Correspondent |
Hogan Lovells US LLP |
555 13th St NW |
Washington,
DC
20004
|
|
Correspondent Contact |
Lina Kontos |
Regulation Number | 884.1425
|
Classification Product Code |
|
Date Received | 06/16/2023 |
Decision Date | 12/20/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|