Sonopuls 190 1631940
Sonopuls 190 1631940 is a Class II device made by Enraf-Nonius B.V., cleared under FDA 510(k) K230472 on 24 Oct 2023 and listed in FDA GUDID since 11 Feb 2025 (UDI-DI 08720618311221), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08720618311221 | Date11 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230472 | Date24 Oct 2023 | StatusActive |
Official records
- AccessGUDID record 08720618311221
- FDA 510(k) database K230472
Across registries
- FDA 510(k) K230472 decided 24 Oct 2023 Active
- FDA GUDID UDI-DI 08720618311221 listed 11 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K230472
- Listed FDA GUDID 08720618311221
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sonopuls 190
- Generic name
- Physical therapy ultrasound system
- Model / reference
- 1631940
- Primary DI / UDI-DI
- 08720618311221
- 510(k) Number
- FDA product code
- IMI
- GMDN term
- Physical therapy ultrasound system
- Device class
- Class II
- Regulation number
- 890.5300
- GUDID distribution status
- In Commercial Distribution
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