The following data is part of a premarket notification filed by Cardionet, Inc with the FDA for Cardionet Ambulatory Ecg Monitor With Arrhythmia Detection, Model Cn1001.
| Device ID | K012241 |
| 510k Number | K012241 |
| Device Name: | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CARDIONET, INC 510 MARKET ST. San Diego, CA 92101 |
| Contact | Donald V Canal |
| Correspondent | Donald V Canal CARDIONET, INC 510 MARKET ST. San Diego, CA 92101 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-17 |
| Decision Date | 2002-02-01 |
| Summary: | summary |