The following data is part of a premarket notification filed by Memtec Corporation with the FDA for Mobileecg 2 Bt.
| Device ID | K181658 |
| 510k Number | K181658 |
| Device Name: | MobileECG 2 BT |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | Memtec Corporation 68 Stiles Road Unit D Salem, NH 03079 |
| Contact | Dennis Garboski |
| Correspondent | Dennis Garboski Memtec Corporation 68 Stiles Road Unit D Salem, NH 03079 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2019-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850033167177 | K181658 | 000 |