Iradimed 3881
Iradimed 3881 is a Class II device made by Iradimed Corporation, cleared under FDA 510(k) K172200 on 25 Oct 2017 and listed in FDA GUDID since 17 Nov 2017 (UDI-DI 00856038001188), 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 | GUDID listing | Number00856038001188 | Date17 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172200 | Date25 Oct 2017 | StatusActive |
Official records
- AccessGUDID record 00856038001188
- FDA 510(k) database K172200
Across registries
- FDA 510(k) K172200 decided 25 Oct 2017 Active
- FDA GUDID UDI-DI 00856038001188 listed 17 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K172200
- Listed FDA GUDID 00856038001188
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Iradimed
- Generic name
- Patient monitoring system module, electrocardiographic
- Model / Ref / Catalog
- 3881
- Primary DI / UDI-DI
- 00856038001188
- 510(k) Number
- FDA product code
- MWI
- GMDN term
- Patient monitoring system module, electrocardiographic
- Device class
- Class II
- Regulation number
- 870.2300
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional