Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K220715
Device Classification Name
Media, Reproductive
More FDA Info for this Device
510(K) Number
K220715
Device Name
Media, Reproductive
Applicant
ARTSMedia Denmark ApS
Kongevejen 149
Virum 2830 DK
Other 510(k) Applications for this Company
Contact
Lotte Stroebech
Other 510(k) Applications for this Contact
Regulation Number
884.6180
More FDA Info for this Regulation Number
Classification Product Code
MQL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/11/2022
Decision Date
02/10/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact