Cleared Traditional

PDT DOSECALCULATOR, MODEL 80000

K000418 · Retinalabs.Com · General Hospital
Oct 2000
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K000418 is an FDA 510(k) clearance for the PDT DOSECALCULATOR, MODEL 80000, a Calculator, Drug Dose (Class II — Special Controls, product code NDC), submitted by Retinalabs.Com (Atlanta, US). The FDA issued a Cleared decision on October 24, 2000, 259 days after receiving the submission on February 8, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K000418 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2000
Decision Date October 24, 2000
Days to Decision 259 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code NDC — Calculator, Drug Dose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890