The following data is part of a premarket notification filed by Infobionic, Inc. with the FDA for Mome Ecg Continuous Detection And Arrhythmia Detector.
| Device ID | K133753 |
| 510k Number | K133753 |
| Device Name: | MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | INFOBIONIC, INC. 600 SUFFOLK STREET P.O. BOX 9719 Lowell, MA 01853 |
| Contact | Carrie Neuberger |
| Correspondent | Carrie Neuberger INFOBIONIC, INC. 600 SUFFOLK STREET P.O. BOX 9719 Lowell, MA 01853 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-09 |
| Decision Date | 2014-09-19 |
| Summary: | summary |