eMurmur Heart AI is an AI-enabled medical device from CSD Labs GmbH that the U.S. FDA cleared through 510(k) K220766 on May 31, 2022. Its lead review panel is Cardiovascular and its primary product code is DQD (Stethoscope, Electronic).
See also FDA-cleared AI cardiovascular devices in 2022, all FDA AI clearances in 2022, top cardiovascular AI devices.
Key facts
| Submission number | K220766 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | CSD Labs GmbH |
| Lead review panel | Cardiovascular |
| Primary product code | DQD — Stethoscope, Electronic |
| Applicant (openFDA) | Csd Labs GmbH |
| Applicant location | Graz, AT |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.1875 |
| Decision code | SESE |
| Submission type | Special |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. eMurmur Heart AI went through this pathway (K220766).
openFDA lists it as a Class 2 device under 21 CFR 870.1875. Class II devices are moderate risk and are subject to general and special controls.
Product code DQD covers 14 devices on the FDA AI list. By decision date, this device is #7 of 14 under that code. CSD Labs GmbH has 2 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
Similar devices (product code DQD)
- Tyto Stethoscope (G3)Tyto Care , Ltd. · Cardiovascular
- Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc. · Cardiovascular
- eMurmur Heart AICsd Labs · Cardiovascular
- Stethophone ProSparrow Acoustics, Inc. · Cardiovascular
- Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc. · Cardiovascular
- AusculThing ACCAusculThing Oy · Cardiovascular