The following data is part of a premarket notification filed by Vitatron Medical Bv with the FDA for Pacemakers, Vitatrons (series 3000).
Device ID | K760671 |
510k Number | K760671 |
Device Name: | PACEMAKERS, VITATRONS (SERIES 3000) |
Classification | Implantable Pacemaker Pulse-generator |
Applicant | VITATRON MEDICAL BV 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXY |
CFR Regulation Number | 870.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-17 |
Decision Date | 1976-11-12 |