The following data is part of a premarket notification filed by Intricon Datrix Corporation with the FDA for Intricon Datrix Centauri Mt Ambulatory Patient Ecg Telemetry System (apets).
| Device ID | K111160 |
| 510k Number | K111160 |
| Device Name: | INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | INTRICON DATRIX CORPORATION 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Tanya O'brien |
| Correspondent | Tanya O'brien INTRICON DATRIX CORPORATION 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-25 |
| Decision Date | 2011-08-01 |
| Summary: | summary |