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FDA 510(k) Application Details - K181260
Device Classification Name
Tonometer, Ac-Powered
More FDA Info for this Device
510(K) Number
K181260
Device Name
Tonometer, Ac-Powered
Applicant
Medimaging Integrated Solution Inc. (MiiS)
1F, No.7, R&D Rd. II
Hsinchu Science Park
Hsinchu 30076 CN
Other 510(k) Applications for this Company
Contact
Chih-Lu Hsu
Other 510(k) Applications for this Contact
Regulation Number
886.1930
More FDA Info for this Regulation Number
Classification Product Code
HKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/11/2018
Decision Date
06/21/2019
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
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