The following data is part of a premarket notification filed by Biomedical Systems Corp. with the FDA for Truvue Wireless Ambulatory Ecg Monitoring System.
| Device ID | K100155 |
| 510k Number | K100155 |
| Device Name: | TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | BIOMEDICAL SYSTEMS CORP. 77 PROGRESS PARKWAY St. Louis, MO 63043 |
| Contact | Michael Kroehnke |
| Correspondent | Michael Kroehnke BIOMEDICAL SYSTEMS CORP. 77 PROGRESS PARKWAY St. Louis, MO 63043 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-20 |
| Decision Date | 2010-04-20 |
| Summary: | summary |