The following data is part of a premarket notification filed by Neurolumen, Llc with the FDA for Neurolumen Pn-1000.
| Device ID | K142025 |
| 510k Number | K142025 |
| Device Name: | NEUROLUMEN PN-1000 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | NEUROLUMEN, LLC 9636 N. May Ave. Oklahoma City, OK 73120 |
| Contact | Doug Durning |
| Correspondent | Andy Thompson Systec Engineering, LLC PO BOX 1123 Euless, TX 76039 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-25 |
| Decision Date | 2015-01-21 |
| Summary: | summary |