ECG Module Kit(AHA) 115-024659-00
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
ECG Module Kit(AHA) 115-024659-00 is a Class II device made by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., cleared under FDA 510(k) K150204 on 10 Apr 2015 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 06944904053097), 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 | Number06944904053097 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK150204 | Date10 Apr 2015 | StatusActive |
Official records
- AccessGUDID record 06944904053097
- FDA 510(k) database K150204
Across registries
- FDA 510(k) K150204 decided 10 Apr 2015 Active
- FDA GUDID UDI-DI 06944904053097 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K150204
- Listed FDA GUDID 06944904053097
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ECG Module Kit(AHA)
- Generic name
- Patient monitoring system module, electrocardiographic
- Model / reference
- 115-024659-00
- Primary DI / UDI-DI
- 06944904053097
- 510(k) Number
- FDA product code
- IYN
- GMDN term
- Patient monitoring system module, electrocardiographic
- Device class
- Class II
- Regulation number
- 892.1550
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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