510(k) clearances

Notal Vision Home Optical Coherence Tomography (OCT) System

Notal Vision, Inc. · Ophthalmic

DEN230043UnknownDirectSAX
Open FDA's page for this record
Third party flag
N
City
Manassas
Advisory committee description
Ophthalmic
Address 1
7717 Coppermine Dr.
Product code
SAX
Zip code
20109
Applicant
Notal Vision, Inc.
Decision date
2024-05-15
Decision code
DENG
Country code
US
Device name
Notal Vision Home Optical Coherence Tomography (OCT) System
Advisory committee
OP
Contact
Kester Nahen
K number
DEN230043
State
VA
Date received
2023-06-07
Review advisory committee
OP
Postal code
20109
Decision description
Unknown
Clearance type
Direct
Harmonized identifiers (openFDA)
Device name
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
Medical specialty description
Ophthalmic
Regulation number
886.1600
Device class
2
Registration number
3008364787, 3004103096
FEI number
3008364787, 3004103096
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.