The following data is part of a premarket notification filed by Cardioline S.p.a with the FDA for Cardioline Touchecg.
| Device ID | K160746 |
| 510k Number | K160746 |
| Device Name: | CARDIOLINE TouchECG |
| Classification | Electrocardiograph |
| Applicant | CARDIOLINE S.p.A VIA LINZ 19-20-21 Z.i. Spini Di Gardolo, IT 38121 |
| Contact | Emanuele Ercoli |
| Correspondent | Alessandro Peluso STUDIO TECNICO ING. PELUSO VIA PRATI 1/2 Zola Predosa-localita Ponte Ronca- Bolog, IT 40069 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-18 |
| Decision Date | 2016-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056732654587 | K160746 | 000 |
| 08056732652903 | K160746 | 000 |