Healthview ECG Manager
by Lumedx
510(k) K123466
Healthview ECG Manager is a Class II device made by Lumedx, cleared under FDA 510(k) K123466 on 20 Dec 2012, 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 | FDA 510(k)SESE | NumberK123466 | Date20 Dec 2012 | StatusActive |
Official records
- FDA 510(k) database K123466
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQK
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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