Fukuda Denshi Cme-77FJKA
Fukuda Denshi Cme-77FJKA is a Class II device made by Fukuda Denshi Co., Ltd., cleared under FDA 510(k) K173226 on 16 Apr 2018 and listed in FDA GUDID since 16 Apr 2024 (UDI-DI 04538612915369), 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 | Number04538612915369 | Date16 Apr 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173226 | Date16 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 04538612915369
- FDA 510(k) database K173226
Across registries
- FDA 510(k) K173226 decided 16 Apr 2018 Active
- FDA GUDID UDI-DI 04538612915369 listed 16 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K173226
- Listed FDA GUDID 04538612915369
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fukuda Denshi
- Generic name
- Electrocardiographic lead set, reusable
- Model / reference
- CME-77FJKA
- Primary DI / UDI-DI
- 04538612915369
- 510(k) Number
- FDA product code
- DPS
- GMDN term
- Electrocardiographic lead set, reusable
- Device class
- Class II
- Regulation number
- 870.2340
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Electrocardiographic lead set, reusable.
- Vital Signs™ Cable for CAM14 for KISS™, 80 cm/31 in 2016560-004 by AirLife Finland Oy
- Patient Cable 9293-017-50 by MORTARA INSTRUMENT, INC.
- Patient Cable 9293-026-50 by MORTARA INSTRUMENT, INC.
- Vital Signs™ 300-series ECG Care Cable, 5-lead, AHA, 3 m/ 10 ft 545303-HEL by AirLife Finland Oy
- ECG 4-lead Extension cbl 2m MP05114 by Dragerwerk AG
- PC ECG BI 12C by Biomedical Instruments Co., Ltd.
- Patient cables and Lead wires by SHENZHEN MEDKE TECHNOLOGY CO., LTD.
- ECG EXT. 5-LEAD DUAL-PIN, 2M MS16492 by Draeger Medical Systems, Inc.
- Kendall 33545 33545- by Cardinal Health 200, LLC