Curapuls 670
510(k) K243112
Curapuls 670 is a Class II device made by Enraf-Nonius B.V., cleared under FDA 510(k) K243112 on 25 Jun 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK243112 | Date25 Jun 2025 | StatusActive |
Official records
- FDA 510(k) database K243112
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IMJ
- FDA applicant
- Enraf-Nonius, B.V.
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5290
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K243112
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Curapuls 670 1670931 | 1670931 | 08720618311177 | — | On the market |
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