The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Meddars Cardiovascular Diagnostic System.
Device ID | K760767 |
510k Number | K760767 |
Device Name: | MEDDARS CARDIOVASCULAR DIAGNOSTIC SYSTEM |
Classification | Computer, Diagnostic, Programmable |
Applicant | HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-04 |
Decision Date | 1976-10-13 |