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510(k) K242304

Device
RED
Applicant
Neuraxis, Inc.
510(k) number
K242304
Product code
KLA
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-06
Date received
2024-08-05
Regulation
876.1725
Classification name
Monitor, Esophageal Motility, Anorectal Motility, And Tube
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Thomas Carrico
Address
11611 N. Meridian St. Suite 330 Carmel IN US 46032 46032

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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