The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Reveal Xt Insertable Cardiac Monitor, Model 9529, Revel Dx Insertable Cardiac Monitor, Model 9528.
Device ID | K082475 |
510k Number | K082475 |
Device Name: | REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 |
Classification | Detector And Alarm, Arrhythmia |
Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET NE MS MV S11 Mounds View, MN 55112 |
Contact | Debbie Kidder |
Correspondent | Debbie Kidder MEDTRONIC INC. 8200 CORAL SEA STREET NE MS MV S11 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 | 2008-08-28 |
Decision Date | 2008-11-07 |
Summary: | summary |