Eli 230 BUR230-A
Eli 230 BUR230-A is a Class II device made by Mortara Instrument, Inc., cleared under FDA 510(k) K100127 on 16 Apr 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345023589), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00812345023589 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100127 | Date16 Apr 2010 | StatusActive |
Official records
- AccessGUDID record 00812345023589
- FDA 510(k) database K100127
Across registries
- FDA 510(k) K100127 decided 16 Apr 2010 Active
- FDA GUDID UDI-DI 00812345023589 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-1810-2020
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Timeline
- Cleared FDA 510(k) K100127
- Listed FDA GUDID 00812345023589
- Recall initiated FDA recalls Z-1810-2020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eli 230
- Generic name
- Electrocardiograph, professional, multichannel
- Model / reference
- BUR230-A
- Primary DI / UDI-DI
- 00812345023589
- 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
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