Eko Analysis Software
510(k) K192004
Eko Analysis Software is a Class II device made by Eko Devices, Inc., cleared under FDA 510(k) K192004 on 15 Jan 2020, 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 | NumberK192004 | Date15 Jan 2020 | StatusActive |
Official records
- FDA 510(k) database K192004
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MWI
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).
- INTEGRATED PATIENT MONITORING SYSTEM by Invivo Research, Inc.
- PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- VITAL SIGNS MONITOR by Mindray North America
- Huma RPM (RPM) by Medopad, Inc.
- Change Healthcare Cardiology Hemodynamics™ by Change Healthcare Israel, Ltd.
- Welch Allyn, Inc. 901058 74RX by Welch Allyn, Inc.
- Welch Allyn, Inc. 901028 85MTVX by Welch Allyn, Inc.
- MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M by Invivo Research, Inc.
- DINAMAP PRO SERIES MONITOR, MODELS 110N, 210N, 310N, 410N by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- Masimo 9783 by MASIMO CORPORATION