510(k) K073087

NON-CONTACT TONOMETER, MODEL FT-1000 by Tomey Corporation — Product Code HKX

K073087 is an FDA 510(k) premarket notification submitted by Tomey Corporation for the device "NON-CONTACT TONOMETER, MODEL FT-1000". The FDA issued a decision of Substantially Equivalent on November 18, 2008. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Tomey Corporation has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2008
Date Received
November 1, 2007
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