The following data is part of a premarket notification filed by Mega Electronics Ltd. with the FDA for Emotion Faros Ecg Mobile.
| Device ID | K143032 |
| 510k Number | K143032 |
| Device Name: | EMotion Faros ECG Mobile |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | MEGA ELECTRONICS LTD. PIONEERINKATU 6 Kuopio, FI 70800 |
| Contact | Taneli Vaaraniemi |
| Correspondent | Taneli Vaaraniemi MEGA ELECTRONICS LTD. PIONEERINKATU 6 Kuopio, FI 70800 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-22 |
| Decision Date | 2015-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035220311 | K143032 | 000 |
| 06430035220175 | K143032 | 000 |
| 06430035220168 | K143032 | 000 |
| 06430035220151 | K143032 | 000 |