The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Centauri Ct Scanner.
Device ID | K840860 |
510k Number | K840860 |
Device Name: | CENTAURI CT SCANNER |
Classification | System, X-ray, Tomography, Computed |
Applicant | TECHNICARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-24 |
Decision Date | 1984-05-22 |