Manufacturer
Pollogen, Ltd.Legend X Platform
Country / Region:Israel (IL)Submission type:Special
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
- K252576
- Device name
- Legend X Platform
- Company
- Pollogen, Ltd.
- Country / Region
- Israel(IL)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-08-14
- Decision date
- 2025-09-12
- Submission type
- Special
Predicate devices
0No predicate K numbers were extracted
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Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252576 as a predicate