The following data is part of a premarket notification filed by Infobionic, Inc. with the FDA for Mome Kardia Wireless Ambulatory Ecg Monitoring And Detection System.
| Device ID | K160064 |
| 510k Number | K160064 |
| Device Name: | MoMe Kardia Wireless Ambulatory ECG Monitoring And Detection System |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | INFOBIONIC, INC. 600 SUFFOLK STREET Lowell, MA 01854 |
| Contact | Nancy Briefs |
| Correspondent | Carrie Neuberger INFOBIONIC, INC. 600 SUFFOLK STREET Lowell, MA 01854 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-13 |
| Decision Date | 2016-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B690MK10 | K160064 | 000 |