The following data is part of a premarket notification filed by Microfile Intellectual Property Gmbh with the FDA for Microlife Digital Infrared Forehead Thermometer, Model Fr1mn1-1.
| Device ID | K161728 |
| 510k Number | K161728 |
| Device Name: | Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MICROFILE INTELLECTUAL PROPERTY GMBH ESPENSTRASSE 139 Widnau, CH 9443 |
| Contact | Gerhard Frick |
| Correspondent | Susan D. Goldstein-falk MDI CONSULTANT, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-22 |
| Decision Date | 2016-12-05 |
| Summary: | summary |