Identity
- Trade Name
- ALGO 7i Patient Cable Short FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- ALGO 7i Patient Cable 36 Inch FDA UDI
- Model / Reference
- 101001 FDA UDI
- Description
- ALGO 7i Patient Cable 36 Inch FDA UDI
Identifiers
- Catalog Number
- A7i-101001 FDA UDI
- Primary DI / UDI-DI
- 04260223145483 FDA UDI
- 510(k) Number
- K211147 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometer
ALGO 7i Patient Cable Short by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K211147 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
- PATH medical GmbH
Sources (1)
- FDA UDI b4e78eaa-3f03-4ad1-a4f9-5d5125144a10 35 fields · synced Jun 8, 2026