Eli 280 BUR280-C1X
Eli 280 BUR280-C1X is a Class II device made by Mortara Instrument, Inc., cleared under FDA 510(k) K122073 on 2 Aug 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345024937), active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00812345024937 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122073 | Date2 Aug 2012 | StatusActive |
Official records
- AccessGUDID record 00812345024937
- FDA 510(k) database K122073
Across registries
- FDA 510(k) K122073 decided 2 Aug 2012 Active
- FDA GUDID UDI-DI 00812345024937 listed 24 Sep 2016 Listed
Recalls
-
- Ongoing Z-0011-2022
The devices malfunction under specific operator workflows.
-
- Terminated Z-1482-2021
Devices do not meet IEC 60601-2-27 requirements as labeled.
Timeline
- Cleared FDA 510(k) K122073
- Listed FDA GUDID 00812345024937
- Recall initiated FDA recalls Z-1482-2021
- Recall initiated FDA recalls Z-0011-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eli 280
- Generic name
- Electrocardiograph, professional, multichannel
- Model / reference
- BUR280-C1X
- Primary DI / UDI-DI
- 00812345024937
- 510(k) Number
- FDA product code
- DPS
- GMDN term
- Electrocardiograph, professional, multichannel
- Device class
- Class II
- Regulation number
- 870.2340
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Electrocardiograph, professional, multichannel.