FDA Product Code
FDA Product Code NTN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K141164 | ARTEMIS LIGHT ENGINE | Quest Medical Imaging | 2015-03-16 | Traditional | PDF ↗ |
| K133311 | ENDOLED | Olympus Winter & Ibe GmbH | 2014-07-30 | Traditional | PDF ↗ |
| K130819 | CLL- V1 LIGHT SOURCE | Olympus Winter & Ibe GmbH | 2013-06-19 | Traditional | PDF ↗ |
| K122831 | VIDEO SYSTEM CENTER | Olympus Medical Systems Corp. | 2012-12-14 | Traditional | PDF ↗ |
| K113679 | LUCEA LED SURGICAL LIGHT SYSTEM | Maquet S.A.S. | 2012-01-12 | Special | PDF ↗ |
| K103813 | SOPRO 281 | Sopro | 2011-03-22 | Traditional | PDF ↗ |
| K102167 | LO-50 LED LIGHT SOURCE | Fiberoptics Technology, Inc. | 2010-08-17 | Traditional | PDF ↗ |
| K091829 | PLS PORTABLE LIGHT SOURCE | Optim, Inc. | 2009-07-28 | Abbreviated | PDF ↗ |
| K090601 | FSC 2 | Schoelly Imaging, Inc. | 2009-05-11 | Traditional | PDF ↗ |
Product code NTN · Class II · Gastroenterology, Urology. Data: openFDA.