AUTOREFRACTOR, SUBJECTIVE

Refractometer, Ophthalmic

CAVITRON CORP.

The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Autorefractor, Subjective.

Pre-market Notification Details

Device IDK781014
510k NumberK781014
Device Name:AUTOREFRACTOR, SUBJECTIVE
ClassificationRefractometer, Ophthalmic
Applicant CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHKO  
CFR Regulation Number886.1760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-06-16
Decision Date1978-09-07

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