The following data is part of a premarket notification filed by Cardionet, Inc with the FDA for Cardionet Ambulatory Ecg Monitor With Arrhythmia Detection.
| Device ID | K093288 |
| 510k Number | K093288 |
| Device Name: | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CARDIONET, INC 1010 2ND AVE., SUITE 700 San Diego, CA 92101 |
| Contact | Kent Sayler |
| Correspondent | Kent Sayler 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 | 2009-10-20 |
| Decision Date | 2010-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B146C5S0 | K093288 | 000 |
| B146C5M0 | K093288 | 000 |
| B146C5M20 | K093288 | 000 |