The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Model Mt18e1-1 (v932-1) Digital Underarm Electronic Thermometer.
| Device ID | K032658 |
| 510k Number | K032658 |
| Device Name: | MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-08-28 |
| Decision Date | 2003-09-11 |
| Summary: | summary |