510(k) K240176

V-VITFREEZE and V-VITWARM by Vitromed GmbH — Product Code MQL

K240176 is an FDA 510(k) premarket notification submitted by Vitromed GmbH for the device "V-VITFREEZE and V-VITWARM". The FDA issued a decision of Substantially Equivalent on September 13, 2024. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Vitromed GmbH has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2024
Date Received
January 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type