FDA.reportPublic FDA data

510(k) K240884

Device
Glide (91000-GL-X)
Applicant
Infinite Biomedical Technologies, LLC
510(k) number
K240884
Product code
GXY
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-15
Date received
2024-04-01
Regulation
882.1320
Classification name
Electrode, Cutaneous
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
Damini Agarwal
Address
8 Market Pl. Suite 500 Baltimore MD US 21202 21202

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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