The following data is part of a premarket notification filed by Edwards Laboratories with the FDA for Computer, Thermodilution Cardiac (9520).
Device ID | K760192 |
510k Number | K760192 |
Device Name: | COMPUTER, THERMODILUTION CARDIAC (9520) |
Classification | Computer, Diagnostic, Pre-programmed, Single-function |
Applicant | EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXG |
CFR Regulation Number | 870.1435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-06 |
Decision Date | 1976-07-19 |