Identity
- Trade Name
- Modular Headstage-36 FDA UDI
- Generic Name
- Electroencephalographic signal amplifier FDA UDI
- Device Name
- The Modular Headstage-36 is a clinical headstage that connects to one of several modular electrode interfaces to connect electrodes from various manufacturers to the ATLAS Neurophysiology System. The Modular Headstage-36 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized. FDA UDI
- Model / Reference
- Modular Headstage-36 FDA UDI
- Description
- The Modular Headstage-36 is a clinical headstage that connects to one of several modular electrode interfaces to connect electrodes from various manufacturers to the ATLAS Neurophysiology System. The Modular Headstage-36 uses electronic components to buffer single unit activity sensed by the electrodes and sends it to the ATLAS Data Acquisition System to be digitized. FDA UDI
Identifiers
- Catalog Number
- 31-0601-0091 FDA UDI
- Primary DI / UDI-DI
- 00850011306130 FDA UDI
- 510(k) Number
- K110967 FDA UDI
- FDA Product Code
- OMC FDA UDI
- GMDN Term
- Electroencephalographic signal amplifier 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
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: Electroencephalographic signal amplifier
Modular Headstage-36 by Neuralynx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalographic signal amplifier.
- XactTrode Patient Cable — Blackrock Microsystems · Class II
- eego amplifier — eemagine Medical Imaging Solutions GmbH · Class II
- XactTrode Patient Cable — Blackrock Microsystems · Class II
- XactTrode Patient Cable — Blackrock Microsystems · Class II
- XactTrode Patient Cable — Blackrock Microsystems · Class II
- Component Neuromonitoring System — Moberg Research, Inc. · Class II
- NATUS NEUROLOGY — Natus Neurology Incorporated · Class II
- XactTrode Patient Cable — Blackrock Microsystems · Class II
Cleared under the same submission
K110967 also covers:
- ATLAS ANALOG ISOLATOR — NEURALYNX, INC.
- ATLAS COMBO BOARD — NEURALYNX, INC.
- ATLAS Ground Drive — NEURALYNX, INC.
- ATLAS HC HEADBOX — NEURALYNX, INC.
- ATLAS HD HEADBOX — NEURALYNX, INC.
- ATLAS HEADBOX — NEURALYNX, INC.
- ATLAS Headbox Expansion Panel — NEURALYNX, INC.
- ATLAS NK HEADBOX — NEURALYNX, INC.
- ATLAS Neurophysiology System — NEURALYNX, INC.
- ATLAS Parallel TTL Cable — NEURALYNX, INC.
- ATLAS Power Isolator 110VAC — NEURALYNX, INC.
- ATLAS Power Isolator 220VAC — NEURALYNX, 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
- Neuralynx, Inc.
Sources (1)
- FDA UDI 25d14403-9ea5-48cd-b922-f721e8c6ba8d 36 fields · synced May 31, 2026