The following data is part of a premarket notification filed by A & D Engineering, Inc. with the FDA for A&d Medical Ut-101 Lifesource Digital Ear Therometer.
| Device ID | K993116 |
| 510k Number | K993116 |
| Device Name: | A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
| Contact | Jerry Wang |
| Correspondent | Jerry Wang A & D ENGINEERING, INC. 1555 MC CANDLESS DR. Milpitas, CA 95035 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-20 |
| Decision Date | 2000-04-12 |