510(k) K840860

CENTAURI CT SCANNER by Technicare Corp. — Product Code JAK

K840860 is an FDA 510(k) premarket notification submitted by Technicare Corp. for the device "CENTAURI CT SCANNER". The FDA issued a decision of Substantially Equivalent on May 22, 1984. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Technicare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1984
Date Received
February 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type