Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K161491
Device Classification Name
More FDA Info for this Device
510(K) Number
K161491
Device Name
Scopis Hybrid Navigation System EM
Applicant
Scopis GmbH
Heinrich-Heine-Platz 10
Berlin 10179 DE
Other 510(k) Applications for this Company
Contact
Christopher Ozbek
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/2016
Decision Date
02/09/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact