The following data is part of a premarket notification filed by Mega Electronics Ltd. with the FDA for Emotion Ecg Mobile.
| Device ID | K131699 |
| 510k Number | K131699 |
| Device Name: | EMOTION ECG MOBILE |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | MEGA ELECTRONICS LTD. Prinsessegracht 20 The Hague, NL 2514 Ap |
| Contact | Andre Kindsvater |
| Correspondent | Andre Kindsvater MEGA ELECTRONICS LTD. Prinsessegracht 20 The Hague, NL 2514 Ap |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-11 |
| Decision Date | 2013-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035220229 | K131699 | 000 |