The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Reveal Linq.
Device ID | K150614 |
510k Number | K150614 |
Device Name: | Reveal LINQ |
Classification | Detector And Alarm, Arrhythmia |
Applicant | MEDTRONIC INC. 8200 CORAL SEA ST NE Mounds View, MN 55112 |
Contact | Dianna L. Johannson |
Correspondent | Dianna L. Johannson MEDTRONIC INC. 8200 CORAL SEA ST 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 | 2015-03-10 |
Decision Date | 2015-08-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00643169782730 | K150614 | 000 |
00643169617254 | K150614 | 000 |
00643169545519 | K150614 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
REVEAL LINQ 98454020 not registered Live/Pending |
Medtronic, Inc. 2024-03-18 |
REVEAL LINQ 85481814 4689006 Live/Registered |
Medtronic, Inc. 2011-11-28 |