Identity
- Trade Name
- ALGO 7i Set 1 FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- ALGO 7i Base Kit containing: 1x 101049 ALGO 7i 1x 101121 ALGO7i Multidata Cable 1x 100524 Power Supply 1x 100525-EU Power Supply Adapter EU 1x 100525-US Power Supply Adapter US 1x 100525-UK Power Supply Adapter UK 1x 100525-AUS Power Supply Adapter AUS 1x 101092-E ALGO 7i Basinet Hook 1x 101100-E ALGO 7i Check Kit 1x 101124-EN ALGO 7i User Manual 1x 101118 USB Stick 1x 100418 USB Cable 1x 101201 ALGO 7i Backback Set FDA UDI
- Model / Reference
- 101127 FDA UDI
- Description
- ALGO 7i Base Kit containing: 1x 101049 ALGO 7i 1x 101121 ALGO7i Multidata Cable 1x 100524 Power Supply 1x 100525-EU Power Supply Adapter EU 1x 100525-US Power Supply Adapter US 1x 100525-UK Power Supply Adapter UK 1x 100525-AUS Power Supply Adapter AUS 1x 101092-E ALGO 7i Basinet Hook 1x 101100-E ALGO 7i Check Kit 1x 101124-EN ALGO 7i User Manual 1x 101118 USB Stick 1x 100418 USB Cable 1x 101201 ALGO 7i Backback Set FDA UDI
Identifiers
- Catalog Number
- A7i-101127 FDA UDI
- Primary DI / UDI-DI
- 04260223145421 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
Yes
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: Evoked-potential audiometer
ALGO 7i Set 1 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
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 2a0ec8e3-5c05-4049-a677-420222592fa0 35 fields · synced Jun 1, 2026