510(k) K091206
- Device
- SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
- Applicant
- TRANSOMA MEDICAL
- 510(k) number
- K091206
- Product code
- MXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-18
- Date received
- 2009-04-24
- Regulation
- 870.2800
- Classification name
- Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LISA STONE
- Address
- 4211 Lexington Ave., N. Suite #2244 St. Paul MN US 55126 55126
FDA Registration Numbers#
- 3012552532
- 2134604
- 3008494315
- 2017865
- 2182208
- 3010659131
Source Documents#
Other 510(k) Records For Product Code MXC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230286 | Assert-IQ™ Insertable Cardiac Monitor | ABBOTT MEDICAL | 2023-05-17 |
| K212206 | Jot Dx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2021-08-13 |
| K202876 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2020-12-01 |
| K202888 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2020-11-23 |
| K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | Abbott (St. Jude Medical) | 2020-03-17 |
| K192593 | Confirm Rx Insertable Cardiac Monitor | Abbott | 2019-10-18 |
| K190295 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2019-04-10 |
| K182981 | Confirm Rx Insertable Cardiac Monitor | Abbott | 2019-03-29 |
| K173232 | myMerlin(TM) Mobile Application Model APP1001 | St Jude Medical | 2017-11-02 |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | St. Jude Medical, Inc. | 2017-09-29 |
| K133481 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) | St. Jude Medical, Inc. | 2014-05-28 |
| K122161 | SJM CONFIRM | St Jude Medical | 2012-11-28 |
| K122090 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-11-15 |
| K101968 | SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A | St Jude Medical | 2010-09-15 |
| K083828 | SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT | Transoma | 2009-02-11 |
Legacy Summary#
summary
FDA Review#
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