T-TYPE D-KAT, R-TYPE D-KAT

Tonometer, Manual

KEELER LIMITED

The following data is part of a premarket notification filed by Keeler Limited with the FDA for T-type D-kat, R-type D-kat.

Pre-market Notification Details

Device IDK133234
510k NumberK133234
Device Name:T-TYPE D-KAT, R-TYPE D-KAT
ClassificationTonometer, Manual
Applicant KEELER LIMITED 456 PARKWAY Broomall,  PA  19008
ContactEugene R Vanarsdale
CorrespondentEugene R Vanarsdale
KEELER LIMITED 456 PARKWAY Broomall,  PA  19008
Product CodeHKY  
CFR Regulation Number886.1930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-21
Decision Date2014-02-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05055272712200 K133234 000
05055272711739 K133234 000

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