Notal Vision Home Optical Coherence Tomography (OCT) System— 510(k) DEN230043

Name: FDA 510(k) clearance DEN230043
Creator: U.S. Food and Drug Administration
Published: 2024-05-15

Unknown

Notal Vision, Inc.

FDA 510(k) clearance DEN230043 for Notal Vision Home Optical Coherence Tomography (OCT) System, Unknown on 2024-05-15. Applicant: Notal Vision, Inc.. Device class: 2.

Clearance details

Applicant: Notal Vision, Inc.
Product code: Code SAX
Device class: Class 2
Regulation: 21 CFR 886.1600
Advisory panel: Ophthalmic
Date received: 2023-06-07
Decision date: 2024-05-15
Decision: Unknown
Clearance type: Direct
Location: Manassas, VA, US

View on FDA.gov ↗

More clearances from Notal Vision, Inc.

view all

K050350 — THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)2005-04-29
K014044 — MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)2002-03-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.