The following data is part of a premarket notification filed by Transoma with the FDA for Sleuth At Implantable Cardiac Monitoring System -6 Cm And 8cm Antenna, Personal Diagnostics Manager (pdm) Accessory Kit.
| Device ID | K083828 |
| 510k Number | K083828 |
| Device Name: | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT |
| Classification | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Applicant | TRANSOMA 119 14TH STREET NW St. Paul, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone TRANSOMA 119 14TH STREET NW St. Paul, MN 55112 |
| Product Code | MXC |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-23 |
| Decision Date | 2009-02-11 |
| Summary: | summary |