BURTON APPLANATION TONOMETER - MODEL T850 & T1000

Tonometer, Ac-powered

R.H. BURTON CO.

The following data is part of a premarket notification filed by R.h. Burton Co. with the FDA for Burton Applanation Tonometer - Model T850 & T1000.

Pre-market Notification Details

Device IDK924777
510k NumberK924777
Device Name:BURTON APPLANATION TONOMETER - MODEL T850 & T1000
ClassificationTonometer, Ac-powered
Applicant R.H. BURTON CO. 3965 BROOKHAM DR. P.O. BOX 68 Grove City,  OH  43123
ContactKevin M Loychik
CorrespondentKevin M Loychik
R.H. BURTON CO. 3965 BROOKHAM DR. P.O. BOX 68 Grove City,  OH  43123
Product CodeHKX  
CFR Regulation Number886.1930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-23
Decision Date1993-04-05

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