The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Digital Infrared Ear Thermometer.
| Device ID | K183663 |
| 510k Number | K183663 |
| Device Name: | Microlife Digital Infrared Ear Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Microlife Intellectual Property GmbH Espenstrasse 139 Widnau, CH 9443 |
| Contact | Gerhard Frick |
| Correspondent | Susan D. Goldstein-falk mdi Consultants, Inc. 55 Northern Blvd , Suite 200 Great Neck, NY 11021 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-27 |
| Decision Date | 2019-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782903039 | K183663 | 000 |
| 00634782603106 | K183663 | 000 |
| 00634782903091 | K183663 | 000 |