The following data is part of a premarket notification filed by Retinalabs.com with the FDA for Pdt Dosecalculator, Model 80000.
| Device ID | K000418 |
| 510k Number | K000418 |
| Device Name: | PDT DOSECALCULATOR, MODEL 80000 |
| Classification | Calculator, Drug Dose |
| Applicant | RETINALABS.COM 1776 PEACHTREE ST. 200 NORTH Atlanta, GA 30309 |
| Contact | Frank Tighe |
| Correspondent | Frank Tighe RETINALABS.COM 1776 PEACHTREE ST. 200 NORTH Atlanta, GA 30309 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-08 |
| Decision Date | 2000-10-24 |