The following data is part of a premarket notification filed by Microlife Corp. with the FDA for Microlife Digital Infrared Ear Thermometer, Ir1dai, Ir1db1, Ir1dd1.
| Device ID | K003308 |
| 510k Number | K003308 |
| Device Name: | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MICROLIFE CORP. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MICROLIFE CORP. 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 | 2000-10-23 |
| Decision Date | 2000-11-14 |