The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Cardiac Probe.
Device ID | K760595 |
510k Number | K760595 |
Device Name: | CARDIAC PROBE |
Classification | Probe, Uptake, Nuclear |
Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IZD |
CFR Regulation Number | 892.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-07 |
Decision Date | 1976-09-17 |