FDA.reportPublic FDA data

ISCREEN VISION INC.

Matched from indexed company URL: ISCREEN, LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
23207493003004358ISCREEN VISION INC.1N2026-01-01748 WALNUT KNOLL LN STE 1 Cordova TN US 38018

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00864218000104iScreen Vision - The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record red reflex images which contain information on ocular status to aid in eye examination. The iScreen Vision Screener 3000 is intended for use solely for a pediatric population by trained professionals.901-201-6132info@iscreenvision.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
706581409173288K102651ISCREEN VISION SCREENERHKI2011-01-12
706581842889061

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HKI12011-01-12

PMN#

GUDID#