Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K190198
Device Classification Name
Camera, Ophthalmic, Ac-Powered
More FDA Info for this Device
510(K) Number
K190198
Device Name
Camera, Ophthalmic, Ac-Powered
Applicant
Nidek Co., Ltd
34-14 Maehama, Hiroishi-cho
Gamagori 443-0038 JP
Other 510(k) Applications for this Company
Contact
Mizuno Yoneji
Other 510(k) Applications for this Contact
Regulation Number
886.1120
More FDA Info for this Regulation Number
Classification Product Code
HKI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/04/2019
Decision Date
04/01/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact