510(k) clearances

EarliPoint System

Earlitec Diagnostics · Neurology

K243891Substantially EquivalentSpecialQPF
Open FDA's page for this record
Third party flag
N
City
Atlanta
Advisory committee description
Neurology
Address 1
755 Commerce Dr., Suite 700
Statement or summary
Summary
Product code
QPF
Zip code
30030
Applicant
Earlitec Diagnostics
Decision date
2025-03-26
Decision code
SESE
Country code
US
Device name
EarliPoint System
Advisory committee
NE
Contact
Ryan Bormann
K number
K243891
State
GA
Date received
2024-12-18
Review advisory committee
NE
Postal code
30030
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Pediatric Autism Spectrum Disorder Diagnosis Aid
Medical specialty description
Neurology
Regulation number
882.1491
Device class
2
Registration number
3020832299, 3027553518
FEI number
3020832299, 3027553518
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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.