ECG 4130
by Vitalograph Ireland, Ltd. 3 variants
ECG 4130 is an electrocardiograph (FDA Class II; FDA product code DXH, Transmitters and Receivers, Electrocardiograph, Telephone) made by Vitalograph Ireland, Ltd., cleared under FDA 510(k) K082077 on 2 Sep 2008 and listed in FDA GUDID since 9 Jul 2021 (UDI-DI 15099169413334), active as of 23 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 | Number15099169413334 | Date9 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082077 | Date2 Sep 2008 | StatusActive |
Official records
- AccessGUDID record 15099169413334
- FDA 510(k) database K082077
Across registries
- FDA 510(k) K082077 decided 2 Sep 2008 Active
- FDA GUDID UDI-DI 15099169413334 listed 9 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K082077
- Listed FDA GUDID 15099169413334
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ECG
- Generic name
- Electrocardiograph, professional, multichannel
- Model / reference
- 4130
- Primary DI / UDI-DI
- 15099169413334
- 510(k) Number
- FDA product code
- DXH
- GMDN term
- Electrocardiograph, professional, multichannel
- Device class
- Class II
- Regulation number
- 870.2920
- GUDID distribution status
- In Commercial Distribution
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