Identity
- Trade Name
- BioGraph Infiniti Advanced Reporting FDA UDI
- Generic Name
- Biofeedback system application software FDA UDI
- Model / Reference
- SA7900AR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540191000647 FDA UDI
- 510(k) Number
- K972723 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Biofeedback system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 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
Yes
FDA UDI
Category: Biofeedback system application software
BioGraph Infiniti Advanced Reporting by Thought Technology Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K972723 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Thought Technology Ltd.
Sources (2)
- FDA UDI 3ac358d1-9961-4f9e-ae04-99772cdf0678 33 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 1, 2026