The following data is part of a premarket notification filed by Transoma Medical with the FDA for Sleuth At Implantable Cardiac Monitoring System-6 And 8cm Antenna, Personal Diagnostic Manager(pdm) Accessory Kit, Model.
| Device ID | K091206 |
| 510k Number | K091206 |
| Device Name: | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL |
| Classification | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Applicant | TRANSOMA MEDICAL 4211 LEXINGTON AVE., NORTH SUITE #2244 St. Paul, MN 55126 -6164 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone TRANSOMA MEDICAL 4211 LEXINGTON AVE., NORTH SUITE #2244 St. Paul, MN 55126 -6164 |
| Product Code | MXC |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-24 |
| Decision Date | 2009-05-18 |
| Summary: | summary |