FDA 510(k) Application Details - K221086

Device Classification Name	More FDA Info for this Device
510(K) Number	K221086
Device Name	CryoRobot Select System
Applicant	TMRW Life Sciences, Inc. 250 Hudson Street Floor 6 New York, NY 10013 US Other 510(k) Applications for this Company
Contact	Christina Miracle Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2022
Decision Date	11/04/2022
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