The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder And Model 6191 Patient Activator.
| Device ID | K994331 |
| 510k Number | K994331 |
| Device Name: | REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR |
| Classification | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Applicant | MEDTRONIC VASCULAR 4000 LEXINGTON AVE. N Shoreview, MN 55126 -2983 |
| Contact | Nora K Hadding |
| Correspondent | Nora K Hadding MEDTRONIC VASCULAR 4000 LEXINGTON AVE. N Shoreview, MN 55126 -2983 |
| Product Code | MXC |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-23 |
| Decision Date | 2000-01-21 |
| Summary: | summary |