The following data is part of a premarket notification filed by Remco Italia S.p.a. with the FDA for Carioline(electrocardiograph).
| Device ID | K852770 |
| 510k Number | K852770 |
| Device Name: | CARIOLINE(ELECTROCARDIOGRAPH) |
| Classification | Electrocardiograph |
| Applicant | REMCO ITALIA S.P.A. 20060 S. PEDRINO DI VIGNATE Milano, Italia(italy), IT |
| Contact | Rivoltana Nuo |
| Correspondent | Rivoltana Nuo REMCO ITALIA S.P.A. 20060 S. PEDRINO DI VIGNATE Milano, Italia(italy), IT |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-28 |
| Decision Date | 1985-08-01 |