PDT Dosecalculator, Model 80000
FDA 510(k) K000418 · Retinalabs.Com
510(k) numberK000418
Submission
- Device name
- PDT Dosecalculator, Model 80000
- Applicant
- Retinalabs.Com
Atlanta, GA, US - Received
- February 8, 2000
- Decision date
- October 24, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDC – Calculator, Drug Dose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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Questions and answers
When was PDT Dosecalculator, Model 80000 cleared by the FDA?
PDT Dosecalculator, Model 80000 (K000418) received a 510(k) decision of Substantially Equivalent on October 24, 2000, 259 days after the submission was received.
What is the product code of K000418?
The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.