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510(k) K133234

T-TYPE D-KAT, R-TYPE D-KAT by Keeler Limited — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2014
Date Received
October 21, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Manual
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

Other clearances by Keeler Limited

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  • K140451 — KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERI (July 11, 2014)
  • K140450 — KEELER KAPTURE SOFTWARE (June 17, 2014)

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