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 Cn1003.
| Device ID | K053263 |
| 510k Number | K053263 |
| Device Name: | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CARDIONET, INC 1010 2ND AVE., SUITE 700 San Diego, CA 92101 |
| Contact | Jack Gaikwad |
| Correspondent | Jack Gaikwad CARDIONET, INC 1010 2ND AVE., SUITE 700 San Diego, CA 92101 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-22 |
| Decision Date | 2006-04-25 |
| Summary: | summary |