The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Digital Infrared Ear Thermometer, Model Ir1de1-1.
| Device ID | K034023 |
| 510k Number | K034023 |
| Device Name: | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MICROLIFE INTELLECTUAL PROPERTY GMBH 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 | 2003-12-29 |
| Decision Date | 2004-01-15 |
| Summary: | summary |