The following data is part of a premarket notification filed by Intelliworks Llc with the FDA for Dual Mode Infrared Thermometer.
| Device ID | K163256 |
| 510k Number | K163256 |
| Device Name: | Dual Mode Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Intelliworks LLC 4910 Wright Road, Ste 120 Stafford, TX 77477 |
| Contact | Dr. Jessica Leonardi |
| Correspondent | Dr. Jessica Leonardi Intelliworks LLC 4910 Wright Road, Ste 120 Stafford, TX 77477 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-04-06 |
| Summary: | summary |