EVRF SYSTEM
FDA 510(k) clearance K130283 · decided 2013-03-07
Clearance details
- K-number
- K130283
- Device name
- EVRF SYSTEM
- Applicant
- F Care Systems NV
- Decision
- Substantially Equivalent
- Date received
- 2013-02-05
- Decision date
- 2013-03-07
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- ONQ
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Crofton, MD, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MED RF 4000 (K210077) | F Care Systems USA, LLC | 2021-12-17 |
| VEIN-GOGH INSTRUMENT (K112334) | Refine USA, LLC | 2012-05-08 |
| VEINWAVE, TC3000 (K083352) | Newlands Clinical Trials, Ltd. | 2009-06-12 |
Recalls involving this device
No recalls on record reference this clearance.