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FDA 510(k) Application Details - K191958
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K191958
Device Name
Hysteroscope (And Accessories)
Applicant
Meditrina, Inc.
1190 Saratoga Avenue, Suite 180
San Jose, CA 95129 US
Other 510(k) Applications for this Company
Contact
Csaba Truckai
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
07/23/2019
Decision Date
10/01/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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