Radioisotope Calibrator Model 34-062
FDA 510(k) K850815 · Victoreen, Inc.
510(k) numberK850815
Submission
- Device name
- Radioisotope Calibrator Model 34-062
- Applicant
- Victoreen, Inc.
Carle Place, NY, US - Received
- February 28, 1985
- Decision date
- August 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Radioisotope Calibrator Model 34-062 cleared by the FDA?
Radioisotope Calibrator Model 34-062 (K850815) received a 510(k) decision of Substantially Equivalent on August 21, 1985, 174 days after the submission was received.
What is the product code of K850815?
The FDA product code is KPT – Calibrator, Dose, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1360.