Foresee Home™ 901F001

GUDID 07290017803005

NOTAL VISION LTD

Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser Macular pigment analyser

• Primary Device ID: 07290017803005
• NIH Device Record Key: 7d723950-776b-40cb-8892-e31e5ee44e8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foresee Home™
• Version Model Number: V2
• Catalog Number: 901F001
• Company DUNS: 532596533
• Company Name: NOTAL VISION LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017803005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091579

FDA Product Code

• HPT: Perimeter, Automatic, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-09
• Device Publish Date: 2021-04-01