The following data is part of a premarket notification filed by Crystal Medtech, Llc with the FDA for Axon Ir Heat Lamp.
| Device ID | K171087 |
| 510k Number | K171087 |
| Device Name: | AXON IR Heat Lamp |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | Crystal Medtech, LLC 4704 Bayberry Street Schofield, WI 54476 |
| Contact | Nelson Marquina |
| Correspondent | Nelson Marquina Crystal Medtech, LLC 4704 Bayberry Street Schofield, WI 54476 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-12 |
| Decision Date | 2017-07-07 |
| Summary: | summary |