True ECG Plus 60135
by Avante
True ECG Plus 60135 is a Class II device made by Avante, cleared under FDA 510(k) K131503 on 25 Feb 2014 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00815871020831), 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 | Number00815871020831 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131503 | Date25 Feb 2014 | StatusActive |
Official records
- AccessGUDID record 00815871020831
- FDA 510(k) database K131503
Across registries
- FDA 510(k) K131503 decided 25 Feb 2014 Active
- FDA GUDID UDI-DI 00815871020831 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K131503
- Listed FDA GUDID 00815871020831
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- True ECG Plus
- Generic name
- Electrocardiograph, professional, multichannel
- Model / reference
- 60135
- Primary DI / UDI-DI
- 00815871020831
- 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-ACCAD by Welch Allyn, Inc.
- Welch Allyn, Inc. 901132 ELI280-LDX-ADFBD by Welch Allyn, Inc.
- ELI 380 ELI380-ACX11 by MORTARA INSTRUMENT, INC.
- ELI 280 ELI280-AAA-AAFBD by MORTARA INSTRUMENT, INC.
- CONTEC ECG1212G by Contec Medical Systems Co., Ltd.
- Kardia 12L AC-027 by AliveCor