FDA 510(k) Application Details - K201970

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K201970
Device Name	Hysteroscope (And Accessories)
Applicant	Schoelly Fiberoptic GmbH Robert-Bosch-Str. 1-3 Denzlingen D-79211 DE Other 510(k) Applications for this Company
Contact	Sandra Baumann 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	07/15/2020
Decision Date	10/08/2020
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