NeoMagic 1943-1608
NeoMagic 1943-1608 is a Class II device made by Neo Medical Inc., cleared under FDA 510(k) K983916 on 23 Nov 1998 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B339194316080), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB339194316080 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK983916 | Date23 Nov 1998 | StatusActive |
Official records
- FDA 510(k) database K983916
Across registries
- FDA 510(k) K983916 decided 23 Nov 1998 Active
- FDA GUDID UDI-DI B339194316080 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K983916
- Listed FDA GUDID B339194316080
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- NeoMagic
- Generic name
- Peripheral intravenous catheterization kit, non-sensing
- Model / Ref / Catalog
- 1943-1608
- Primary DI / UDI-DI
- B339194316080
- 510(k) Number
- FDA product code
- FOZ
- GMDN term
- Peripheral intravenous catheterization kit, non-sensing
- Device class
- Class II
- Regulation number
- 880.5200
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Length — 8 CentimeterCatheter Gauge — 1.9 French
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