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Ahead Electrode Headset

FDA UDI

Class II (US FDA UDI)

by Brainscope

Identity

Trade Name
Ahead Electrode Headset FDA UDI
Generic Name
Electroencephalographic electrode cap, single-use FDA UDI
Model / Reference
99-1403-202 FDA UDI

Identifiers

Primary DI / UDI-DI
00852745007031 FDA UDI
510(k) Number
K161068 FDA UDI
FDA Product Code
OLU FDA UDI
PKQ FDA UDI
PIW FDA UDI
GMDN Term
Electroencephalographic electrode cap, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
882.1470 FDA UDI
882.1450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electroencephalographic electrode cap, single-use

Ahead Electrode Headset by Brainscope — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalographic electrode cap, single-use.

Cleared under the same submission

K161068 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Brainscope

Sources (1)

  • FDA UDI afaf9870-8140-4f1f-bca5-ab5da95e7138 34 fields · synced May 30, 2026