510(k) K233846

Vitrification Solution Set and Warming Solution Set by Ecmpc, LLC — Product Code MQL

K233846 is an FDA 510(k) premarket notification submitted by Ecmpc, LLC for the device "Vitrification Solution Set and Warming Solution Set". The FDA issued a decision of Substantially Equivalent on August 27, 2024. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2024
Date Received
December 4, 2023
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