Identity
- Trade Name
- Natus FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- EMU40 DIGITAL BOX WHITE FDA UDI
- Model / Reference
- 10405 FDA UDI
- Description
- EMU40 DIGITAL BOX WHITE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830000116 FDA UDI
- 510(k) Number
- K053386 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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
Yes
FDA UDI
Category: Electroencephalograph
Natus by Xltek — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalograph.
- Natus — Natus Neurology Incorporated · Class II
- Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
- Natus — Natus Neurology Incorporated · Class II
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc. · Class II
- 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
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
- Xltek
Sources (1)
- FDA UDI c6733e67-db17-452c-86e7-f4c7ff0ac67b 34 fields · synced May 30, 2026