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510(k) K181143

Keeler TonoCare Tonometer by Keeler Instruments, Inc. — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2019
Date Received
May 1, 2018
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

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  • K973064 — KEELER TEARSCOPE-PLUS (April 7, 1998)
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