PDT DOSECALCULATOR, MODEL 80000— 510(k) K000418
Substantially EquivalentRetinalabs.Com
FDA 510(k) clearance K000418 for PDT DOSECALCULATOR, MODEL 80000, Substantially Equivalent on 2000-10-24. Applicant: Retinalabs.Com. Device class: 2.
Clearance details
- Applicant
- Retinalabs.Com
- Product code
- Code NDC
- Device class
- Class 2
- Regulation
- 21 CFR 868.1890
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
Recent devices under product code NDC
view allMore clearances from Retinalabs.Com
view all- K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
- K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
- K000416 — TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
- K000420 — SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
Adverse events under product code NDC
product code NDC- Malfunction
- 1,390
- Total
- 1,390
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.