Company · US
Infobionic, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 29, 2025 | K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) Infobionic, Inc. | DSI |
| Oct 6, 2023 | K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System Infobionic, Inc. | DSI |
| Mar 11, 2016 | K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System Infobionic, Inc. | QYX |
| Dec 17, 2015 | K152491 | MoMe Software Platform Infobionic, Inc. | DSI |
| Sep 19, 2014 | K133753 | MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR Infobionic, Inc. | QYX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||