The following data is part of a premarket notification filed by Vitatron Medical Bv with the FDA for Va 1000.
Device ID | K791380 |
510k Number | K791380 |
Device Name: | VA 1000 |
Classification | Tester, Pacemaker Electrode Function |
Applicant | VITATRON MEDICAL BV 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTA |
CFR Regulation Number | 870.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-24 |
Decision Date | 1979-09-19 |