ELI 150c ELI150c-AAA-AACAD
ELI 150c ELI150c-AAA-AACAD is a Class II device made by Mortara Instrument, Inc., cleared under FDA 510(k) K101115 on 18 Jun 2010 and listed in FDA GUDID since 11 Aug 2017 (UDI-DI 00817655021867), 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 | Number00817655021867 | Date11 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK101115 | Date18 Jun 2010 | StatusActive |
Official records
- AccessGUDID record 00817655021867
- FDA 510(k) database K101115
Across registries
- FDA 510(k) K101115 decided 18 Jun 2010 Active
- FDA GUDID UDI-DI 00817655021867 listed 11 Aug 2017 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) K101115
- Listed FDA GUDID 00817655021867
- Recall initiated FDA recalls Z-1810-2020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ELI 150c
- Generic name
- Electrocardiograph, professional, multichannel
- Model / reference
- ELI150c-AAA-AACAD
- Primary DI / UDI-DI
- 00817655021867
- 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.
- Welch Allyn, Inc. 901132 ELI280-BDB-AACBD by Welch Allyn, Inc.
- Welch Allyn, Inc. 901129 ELI150C-GDA-ABCBB by Welch Allyn, Inc.
- Electrocardiograph SE-300B by Edan Instruments, Inc.
- Kardia 12L AC-027 by AliveCor
- ELI 280 ELI280-AAA-ABFBX by MORTARA INSTRUMENT, INC.
- ELI 280 ELI280-CAA-AAFBT by MORTARA INSTRUMENT, INC.