Identity
- Trade Name
- SmartScreener-Plus2 AEP Module FDA UDI
- Generic Name
- Bioelectrical signal analysis software FDA UDI
- Model / Reference
- M812001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817020020839 FDA UDI
- 510(k) Number
- K090579 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Bioelectrical signal analysis software 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bioelectrical signal analysis software
SmartScreener-Plus2 AEP Module 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
K090579 also covers:
- Aria — Intelligent Hearing Systems Corp.
- Screener Cart — Intelligent Hearing Systems Corp.
- Screener Cart (TUV Listed) — Intelligent Hearing Systems Corp.
- SmartScreener-Plus2 OAE Module — Intelligent Hearing Systems Corp.
- SmartScreener-Plus2 Screener Launch — Intelligent Hearing Systems Corp.
- USBLite Cart Sound-Output-Electrode Box w 10D Grounded — 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 364d2638-b25b-4d68-8ae0-8d47b4c087d1 33 fields · synced Jun 8, 2026