Manufacturer
F Care Systems USA, LLCVeineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K253918
- Device name
- Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
- Company
- F Care Systems USA, LLC
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-12-08
- Decision date
- 2026-06-02
- Submission type
- Traditional
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K253918 as a predicate