The following data is part of a premarket notification filed by Infobionic, Inc. with the FDA for Mome Software Platform.
| Device ID | K152491 |
| 510k Number | K152491 |
| Device Name: | MoMe Software Platform |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | INFOBIONIC, INC. 600 SUFFOLK STREET Lowell, MA 01854 |
| Contact | Matthew King |
| Correspondent | Matthew King INFOBIONIC, INC. 600 SUFFOLK STREET Lowell, MA 01854 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-01 |
| Decision Date | 2015-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B690MS10 | K152491 | 000 |