FDA-recognized standard · Software/Informatics
IEEE 11073-10406-2023: Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
Yes. FDA recognizes IEEE Std 11073-10406-2023 as recognition 13-147, entered 2025-05-26.
Recognized editions of IEEE 11073-10406-2023
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 13-147 | IEEE Std 11073-10406-2023 | 2025-05-26 | Complete | — |
Regulations
FDA lists these classification regulations against IEEE 11073-10406-2023: 21 CFR 870.2300, 21 CFR 870.2340.
Product codes that cite IEEE 11073-10406-2023
5 FDA product codes cite IEEE 11073-10406-2023, including DPS, DRT, MLC, MSX, MWI.
- DPS Electrocardiograph
- DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MLC
- MSX System, Network And Communication, Physiological Monitors
- MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.