The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Model 2331t Patient Programmer.
Device ID | K880738 |
510k Number | K880738 |
Device Name: | MODEL 2331T PATIENT PROGRAMMER |
Classification | Programmer, Pacemaker |
Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
Contact | H Swanson |
Correspondent | H Swanson MEDTRONIC VASCULAR 7000 CENTRAL AVE. N.E. Minneapolis, MN 55432 |
Product Code | KRG |
CFR Regulation Number | 870.3700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-24 |
Decision Date | 1988-11-17 |