The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Thermodilution Kit.
Device ID | K811480 |
510k Number | K811480 |
Device Name: | THERMODILUTION KIT |
Classification | Probe, Thermodilution |
Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRB |
CFR Regulation Number | 870.1915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-27 |
Decision Date | 1981-06-09 |