The following data is part of a premarket notification filed by Medical Graphics Corp. with the FDA for Mida System, Models 1000/1100.
Device ID | K896396 |
510k Number | K896396 |
Device Name: | MIDA SYSTEM, MODELS 1000/1100 |
Classification | Vectorcardiograph |
Applicant | MEDICAL GRAPHICS CORP. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
Contact | Constance G Bundy |
Correspondent | Constance G Bundy MEDICAL GRAPHICS CORP. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
Product Code | DYC |
CFR Regulation Number | 870.2400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-06 |
Decision Date | 1990-01-18 |