Device Classification Name |
Labware, Assisted Reproduction
|
510(k) Number |
K181461 |
Device Name |
Rapid-i™ Kit |
Applicant |
Vitrolife Sweden AB |
Gustaf Werners gata 2 |
Vastra Frolunda,
SE
421 32
|
|
Applicant Contact |
Nina Arvidsson |
Correspondent |
Vitrolife Sweden AB |
Gustaf Werners gata 2 |
SE-421 32 Vastra Frolunda,
SE
|
|
Correspondent Contact |
Nina Arvidsson |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 06/04/2018 |
Decision Date | 01/04/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|