Identity
- Trade Name
- BrainScope One FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- This record is for BrainScope Part Number 99-1801-200 (SKU: BSO-3001) which is the BrainScope Ahead 500 CUBC1 Kit. Contains Device Identifier (DI) 00852745007277 - this is the DI for the BrainScope One (CUBC1) Device (BrainScope Part Number 50-1801-203) FDA UDI
- Model / Reference
- Ahead 500 CUBC1 FDA UDI
- Description
- This record is for BrainScope Part Number 99-1801-200 (SKU: BSO-3001) which is the BrainScope Ahead 500 CUBC1 Kit. Contains Device Identifier (DI) 00852745007277 - this is the DI for the BrainScope One (CUBC1) Device (BrainScope Part Number 50-1801-203) FDA UDI
Identifiers
- Catalog Number
- BSO-3001 FDA UDI
- Primary DI / UDI-DI
- 00852745007284 FDA UDI
- 510(k) Number
- K190815 FDA UDI
- FDA Product Code
- OLU FDA UDIPKQ FDA UDIPIW FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI882.1470 FDA UDI882.1450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Electroencephalograph
BrainScope One by Brainscope — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalograph.
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- Natus — Natus Neurology Incorporated · Class II
- 128-channel EEG cap (L) — Megin Oy · Class II
- Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
- Zeto ONE Head Unit - Small — ZETO INC · Class II
Cleared under the same submission
K190815 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Brainscope
Sources (1)
- FDA UDI a2064658-6d00-433a-a259-37658c26f859 36 fields · synced Jun 8, 2026