ECG cable X
by CNSystems Medizintechnik GmbH
ECG cable X (00021) is a Class II device made by CNSystems Medizintechnik GmbH, cleared under FDA 510(k) K014063 on 7 Feb 2002 and listed in FDA GUDID since 28 Nov 2018 (UDI-DI 09120073931801), active as of 23 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 | Number09120073931801 | Date28 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK014063 | Date7 Feb 2002 | StatusActive |
Official records
- AccessGUDID record 09120073931801
- FDA 510(k) database K014063
Across registries
- FDA 510(k) K014063 decided 7 Feb 2002 Active
- FDA GUDID UDI-DI 09120073931801 listed 28 Nov 2018 Listed
Recalls
-
- Terminated Z-0572-2016
Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic blood pressure).
Timeline
- Cleared FDA 510(k) K014063
- Recall initiated FDA recalls Z-0572-2016
- Listed FDA GUDID 09120073931801
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ECG cable
- Generic name
- General-purpose multi-parameter bedside monitor
- Model / Ref / Catalog
- X, 00021
- Primary DI / UDI-DI
- 09120073931801
- 510(k) Number
- FDA product code
- DSB
- GMDN term
- General-purpose multi-parameter bedside monitor
- Device class
- Class II
- Regulation number
- 870.2770
- GUDID distribution status
- In Commercial Distribution