Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165

FDA 510(k) K030066 · Nuclear Associates

Substantially Equivalent

510(k) numberK030066

Submission

Device name
Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165
Applicant
Nuclear Associates
Hicksville, NY, US
Received
January 7, 2003
Decision date
August 29, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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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Questions and answers

When was Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165 cleared by the FDA?

Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165 (K030066) received a 510(k) decision of Substantially Equivalent on August 29, 2003, 234 days after the submission was received.

What is the product code of K030066?

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