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510(k) K060780

TONOMETER DIATON by Ryazan State Instruments — Product Code HKX

K060780 is an FDA 510(k) premarket notification submitted by Ryazan State Instruments for the device "TONOMETER DIATON". The FDA issued a decision of Substantially Equivalent on April 6, 2006. 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
April 6, 2006
Date Received
March 22, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
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  • K162067 — VX130 Ophthalmic Diagnostic Device (April 24, 2017)
  • K143086 — VX120 Ophthalmic Diagnostic Device (June 1, 2015)
  • K113066 — CORVIS ST (November 8, 2012)
  • K111710 — FULL AUTO TONOMETER MODEL TX-20 (September 20, 2011)

FDA data resources