Modification to Standard Imaging PT 1000 Ion Chamber
FDA 510(k) K002833 · Standard Imaging, Inc.
510(k) numberK002833
Submission
- Device name
- Modification to Standard Imaging PT 1000 Ion Chamber
- Applicant
- Standard Imaging, Inc.
Middleton, WI, US - Received
- September 12, 2000
- Decision date
- September 28, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Modification to Standard Imaging PT 1000 Ion Chamber cleared by the FDA?
Modification to Standard Imaging PT 1000 Ion Chamber (K002833) received a 510(k) decision of Substantially Equivalent on September 28, 2000, 16 days after the submission was received.
What is the product code of K002833?
The FDA product code is KPT – Calibrator, Dose, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1360.