The following data is part of a premarket notification filed by Quest Medical Imaging with the FDA for Artemis Light Engine.
| Device ID | K141164 |
| 510k Number | K141164 |
| Device Name: | ARTEMIS LIGHT ENGINE |
| Classification | Led Light Source |
| Applicant | QUEST MEDICAL IMAGING 526 S Main St Akron, OH 44311 |
| Contact | Martin Heuvelmans |
| Correspondent | Martin Heuvelmans QUEST MEDICAL IMAGING 526 S Main St Akron, OH 44311 |
| Product Code | NTN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-05 |
| Decision Date | 2015-03-16 |
| Summary: | summary |