The following data is part of a premarket notification filed by Microlife Corp. with the FDA for Microlife Digital Infrared Ear Thermometer, Model Ir1da1.
| Device ID | K000969 |
| 510k Number | K000969 |
| Device Name: | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DA1 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2000-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782564957 | K000969 | 000 |
| 00634782562755 | K000969 | 000 |