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Digital NeuroPort Biopotential Signal Processing System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Digital NeuroPort Biopotential Signal Processing System FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Sterile Digital Data Cable 1.5m FDA UDI
- Model / Reference
- 11058 FDA UDI
- Description
- Sterile Digital Data Cable 1.5m FDA UDI
Identifiers
- Catalog Number
- 11058 FDA UDI
- Primary DI / UDI-DI
- 00814901021367 FDA UDI
- 510(k) Number
- K202174 FDA UDI
- FDA Product Code
- GWK FDA UDIGWL FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1845 FDA UDI882.1835 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Feet FDA UDI
Category: Electrical-only medical device connection cable, reusable
Digital NeuroPort Biopotential Signal Processing System by Blackrock Microsystems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrical-only medical device connection cable, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
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- ECG Cable — Edan Instruments,Inc. · Class I
Cleared under the same submission
K202174 also covers:
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- Digital NeuroPort Biopotential Signal Processing System — Blackrock Microsystems
- NeuroPlex E128 — Blackrock Microsystems
- NeuroPlex E128 Sterile — Blackrock Microsystems
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
- Blackrock Microsystems
Sources (1)
- FDA UDI 09265051-6a7f-4c9f-86d2-5bf0a504d5bd 37 fields · synced Jun 1, 2026