FDA.reportPublic FDA data

510(k) K210805

Device
Ceribell Instant EEG Headband
Applicant
Ceribell, Inc.
510(k) number
K210805
Product code
GXY
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-30
Date received
2021-03-17
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
No

Applicant Contact#

Contact
Raymond Woo
Address
2483 Old Middlefield Way Suite 120 Mountainview CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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