The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Reveal Linq Insertable Cardiac Monitor.
| Device ID | K132649 |
| 510k Number | K132649 |
| Device Name: | REVEAL LINQ INSERTABLE CARDIAC MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Eric Kalmes |
| Correspondent | Eric Kalmes MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-26 |
| Decision Date | 2014-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169547940 | K132649 | 000 |
| 00643169508262 | K132649 | 000 |
| 00643169323575 | K132649 | 000 |