The following data is part of a premarket notification filed by Eas Consulting Group Llc with the FDA for Thermotex Platinum System.
| Device ID | K092589 |
| 510k Number | K092589 |
| Device Name: | THERMOTEX PLATINUM SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | EAS CONSULTING GROUP LLC 1940 DUKE ST., SUITE 200 Alexandria, VA 22314 |
| Contact | Eduardo March |
| Correspondent | Eduardo March EAS CONSULTING GROUP LLC 1940 DUKE ST., SUITE 200 Alexandria, VA 22314 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-24 |
| Decision Date | 2010-01-28 |
| Summary: | summary |