The following data is part of a premarket notification filed by Neurolumen, Llc with the FDA for Neutrolumenpn System, Model 1000.
| Device ID | K082223 |
| 510k Number | K082223 |
| Device Name: | NEUTROLUMENPN SYSTEM, MODEL 1000 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | NEUROLUMEN, LLC 11108 ASHFORD DRIVE Yukon, OK 73099 |
| Contact | Shelly Henry |
| Correspondent | Shelly Henry NEUROLUMEN, LLC 11108 ASHFORD DRIVE Yukon, OK 73099 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-06 |
| Decision Date | 2009-04-21 |