Prestodr 4143
by CMT Medical Technologies, Ltd.
510(k) K110849
Prestodr 4143 is a Class II device made by CMT Medical Technologies, Ltd., cleared under FDA 510(k) K110849 on 26 Apr 2011, 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 | NumberK110849 | Date26 Apr 2011 | StatusActive |
Official records
- FDA 510(k) database K110849
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPR
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K110849
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 | |||
|---|---|---|---|---|
| Presto DR 3543 EZ Optimum 62821378 | 62821378 | 07290012104824 | — | On the market |
| Presto DR 4143Optimum 1004143 | 1004143 | 07290012104800 | — | On the market |
| Presto DR 4343Optimum 62498035 | 62498035 | 07290012104817 | — | On the market |
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