Clinicomp RDMS Radionuclide Dispensing Mgmt. Softw

FDA 510(k) K850838 · Clinicomp, Inc.

Substantially Equivalent

510(k) numberK850838

Submission

Device name
Clinicomp RDMS Radionuclide Dispensing Mgmt. Softw
Applicant
Clinicomp, Inc.
Huntington Woods, MI, US
Received
March 1, 1985
Decision date
September 26, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KPT – Calibrator, Dose, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1360
Specialty
Radiology

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More from Mentor Corp.

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Questions and answers

When was Clinicomp RDMS Radionuclide Dispensing Mgmt. Softw cleared by the FDA?

Clinicomp RDMS Radionuclide Dispensing Mgmt. Softw (K850838) received a 510(k) decision of Substantially Equivalent on September 26, 1985, 209 days after the submission was received.

What is the product code of K850838?

The FDA product code is KPT – Calibrator, Dose, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1360.