The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Dual Mode Thermometer,model Ifr1mj1.
| Device ID | K113141 |
| 510k Number | K113141 |
| Device Name: | MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BOULEVARD SUITE 200 Great Neck, NY 10021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BOULEVARD SUITE 200 Great Neck, NY 10021 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-24 |
| Decision Date | 2012-01-27 |
| Summary: | summary |