Identity
- Trade Name
- X-Series FDA UDI
- Generic Name
- Patient monitoring system module, electroencephalographic FDA UDI
- Device Name
- X-Small 10-20 Universal Strip FDA UDI
- Model / Reference
- XS30-4250 FDA UDI
- Description
- X-Small 10-20 Universal Strip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850015266713 FDA UDI
- 510(k) Number
- K131383 FDA UDI
- FDA Product Code
- OMC FDA UDIGWQ FDA UDI
- GMDN Term
- Patient monitoring system module, electroencephalographic 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient monitoring system module, electroencephalographic
A comprehensive medical device directory listing the X-Series device, including its features, compliance, and FAQs.
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Cleared under the same submission
K131383 also covers:
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
- X-Series — Advanced Brain Monitoring, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Brain Monitoring, Inc.
Sources (1)
- FDA UDI 9d691038-133f-4a90-8ce3-d348a0710fda 34 fields · synced Jul 30, 2026