Eltrac 471
510(k) K151640
Eltrac 471 is a Class II device made by Enraf-Nonius B.V., cleared under FDA 510(k) K151640 on 16 Oct 2015, 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 | NumberK151640 | Date16 Oct 2015 | StatusActive |
Official records
- FDA 510(k) database K151640
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ITH
- FDA applicant
- Enraf-Nonius, B.V.
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5900
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K151640
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 | |||
|---|---|---|---|---|
| Dynatron SmarTRAC DSTC1 | DSTC1 | 10660584000451 | Weight 22 lb; Width 11.8 in; Length 13.4 in; Height 8.7 in | On the market |
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