The following data is part of a premarket notification filed by Contex International Technologies (canada), Inc. with the FDA for Nowcardio System.
| Device ID | K162956 |
| 510k Number | K162956 |
| Device Name: | NOWCARDIO SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC. 2798 THAMESGATE DRIVE, UNITS 5&6 Mississauga, CA L4t 4e8 |
| Contact | Ricardo Rodriguez |
| Correspondent | Ricardo Rodriguez CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC. 2798 THAMESGATE DRIVE, UNITS 5&6 Mississauga, CA L4t 4e8 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-24 |
| Decision Date | 2017-09-22 |
| Summary: | summary |