510(k) K223739

VS Tabletop Tonometer by Medimaging Integrated Solution, Inc. — Product Code HKX

K223739 is an FDA 510(k) premarket notification submitted by Medimaging Integrated Solution, Inc. for the device "VS Tabletop Tonometer". The FDA issued a decision of Substantially Equivalent on November 8, 2023. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2023
Date Received
December 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type