Identity
- Trade Name
- SmartEP Software FDA UDI
- Generic Name
- Bioelectrical signal analysis software FDA UDI
- Model / Reference
- M811000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817020020808 FDA UDI
- 510(k) Number
- K070608 FDA UDI
- FDA Product Code
- GWF FDA UDIGWE FDA UDIGWJ FDA UDI
- GMDN Term
- Bioelectrical signal analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 FDA UDI882.1890 FDA UDI882.1900 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bioelectrical signal analysis software
SmartEP Software by Intelligent Hearing Systems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bioelectrical signal analysis software.
- Synchrony Dysphagia Solutions by ACP — ACCELERATED CARE PLUS CORP. · Class II
- MyoVision Software — PRECISION BIOMETRICS INC · Class II
- OmniME — ACCELERATED CARE PLUS CORP. · Class I
- encevis — AIT Austrian Institute of Technology GmbH · Class II
- MyoVision Software — PRECISION BIOMETRICS INC · Class II
- encevis — AIT Austrian Institute of Technology GmbH · Class II
- MyoVision Software — PRECISION BIOMETRICS INC · Class I
- CNS Envision — Natus Neurology Incorporated · Class II
Cleared under the same submission
K070608 also covers:
- Electrical Stimulation Box — Intelligent Hearing Systems Corp.
- Electrical Stimulator Probe — Intelligent Hearing Systems Corp.
- USB to Electrical Stimulation Box Cable — Intelligent Hearing Systems Corp.
- Universal Smart Box — Intelligent Hearing Systems Corp.
- Visual Stimulation Box — Intelligent Hearing Systems Corp.
- eABR Cable — Intelligent Hearing Systems Corp.
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
- Intelligent Hearing Systems Corp.
Sources (1)
- FDA UDI d1fd6522-2e5c-4f93-8681-00902c85c3ba 33 fields · synced Jun 8, 2026