Visibly Digital Acuity Product

Digital Visual Acuity Test

Visibly, Inc.

The following data is part of a premarket notification filed by Visibly, Inc. with the FDA for Visibly Digital Acuity Product.

Pre-market Notification Details

Device IDK220090
510k NumberK220090
Device Name:Visibly Digital Acuity Product
ClassificationDigital Visual Acuity Test
Applicant Visibly, Inc. 207 E Ohio Street, #233 Chicago,  IL  60611
ContactPaul Foley
CorrespondentJanice M. Hogan
Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia,  PA  19103
Product CodeQTO  
CFR Regulation Number886.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-11
Decision Date2022-08-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850038376000 K220090 000

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