The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Reveal Dx Insertable Cardiac Monitor, Reveal Patient Assistant, Model(s) 9528,9538.
| Device ID | K071655 |
| 510k Number | K071655 |
| Device Name: | REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET NW Mounds View, MN 55112 |
| Contact | Michelle Nivala |
| Correspondent | Michelle Nivala MEDTRONIC INC. 8200 CORAL SEA STREET NW 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 | 2007-06-18 |
| Decision Date | 2007-11-21 |
| Summary: | summary |