APPLANATION TONOMETER

Tonometer, Ac-powered

OPTILASA S.L.

The following data is part of a premarket notification filed by Optilasa S.l. with the FDA for Applanation Tonometer.

Pre-market Notification Details

Device IDK023676
510k NumberK023676
Device Name:APPLANATION TONOMETER
ClassificationTonometer, Ac-powered
Applicant OPTILASA S.L. 338 ARTURO SORIA ST. Madrid,  ES 28033
ContactJose M Bobes
CorrespondentJose M Bobes
OPTILASA S.L. 338 ARTURO SORIA ST. Madrid,  ES 28033
Product CodeHKX  
CFR Regulation Number886.1930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-01
Decision Date2003-04-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00869228000441 K023676 000
00851158007119 K023676 000
00851158007102 K023676 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.