FDA 510(k) Application Details - K192811

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K192811
Device Name	Hysteroscope (And Accessories)
Applicant	Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 US Other 510(k) Applications for this Company
Contact	Vicki Gail Other 510(k) Applications for this Contact
Regulation Number	884.1690   More FDA Info for this Regulation Number
Classification Product Code	HIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2019
Decision Date	10/23/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review