The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic 5311 Pacing System Analyzer.
| Device ID | K850077 |
| 510k Number | K850077 |
| Device Name: | MEDTRONIC 5311 PACING SYSTEM ANALYZER |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
| Contact | Martin E Kienitz |
| Correspondent | Martin E Kienitz MEDTRONIC VASCULAR 800 53RD AVENUE, NE P.O. BOX 1250 Minneapolis, MN 55440 -9087 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-09 |
| Decision Date | 1985-07-16 |