Identity
- Trade Name
- MyoVision Software FDA UDI
- Generic Name
- Bioelectrical signal analysis software FDA UDI
- Device Name
- Software FDA UDI
- Model / Reference
- Feature Pack B FDA UDI
- Description
- Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853818007071 FDA UDI
- 510(k) Number
- K123399 FDA UDI
- FDA Product Code
- KQX FDA UDIHCS FDA UDIHCC FDA UDIIKN FDA UDI
- GMDN Term
- Bioelectrical signal analysis software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1500 FDA UDI882.1570 FDA UDI882.5050 FDA UDI890.1375 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
MyoVision Software by Precision Biometrics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123399 also covers:
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- MyoVision Software — PRECISION BIOMETRICS INC
- MyoVision Software — PRECISION BIOMETRICS INC
- MyoVision Software — PRECISION BIOMETRICS INC
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 I | Pending data |
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Manufacturer
- Manufacturer
- Precision Biometrics Inc
Sources (1)
- FDA UDI 203c1cba-2603-419a-9cc8-54d79934c362 34 fields · synced Jun 6, 2026