Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K142263
Device Classification Name
Tonometer, Manual
More FDA Info for this Device
510(K) Number
K142263
Device Name
Tonometer, Manual
Applicant
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD.
Zone A, 2nd Floor, No. 69, Lane
1985, Chunshen Road, Minhang District,
SHANGHAI 200237 CN
Other 510(k) Applications for this Company
Contact
Weida Zhan
Other 510(k) Applications for this Contact
Regulation Number
886.1930
More FDA Info for this Regulation Number
Classification Product Code
HKY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/14/2014
Decision Date
04/15/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact