The following data is part of a premarket notification filed by Thermidas Americas, Inc. with the FDA for Thermidas Ir System (thir-a615).
| Device ID | K200999 |
| 510k Number | K200999 |
| Device Name: | Thermidas IR System (ThIR-A615) |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | Thermidas Americas, Inc. 7912 Sailboat Key Blvd., Suite 508 South Pasadena, FL 33707 |
| Contact | Karo Kujanpaa |
| Correspondent | Samantha L Prokop Gunster, Yoakley & Stewart, P.A. 225 Water Street, Suite 1750 Jacksonville, FL 32202 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-16 |
| Decision Date | 2021-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06429810718006 | K200999 | 000 |
| 06429810718020 | K200999 | 000 |
| 06429810718013 | K200999 | 000 |