Point to Point Level
FDA 510(k) K800761 · Radiation Products Design, Inc.
510(k) numberK800761
Submission
- Device name
- Point to Point Level
- Applicant
- Radiation Products Design, Inc.
Mchenry, IL, US - Received
- April 4, 1980
- Decision date
- May 14, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Point to Point Level cleared by the FDA?
Point to Point Level (K800761) received a 510(k) decision of Substantially Equivalent on May 14, 1980, 40 days after the submission was received.
What is the product code of K800761?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.