The following data is part of a premarket notification filed by Biocare Asia Corporation Ltd. with the FDA for Digital Thermometer.
| Device ID | K161211 |
| 510k Number | K161211 |
| Device Name: | Digital Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | BIOCARE ASIA CORPORATION LTD. NO.260, MAYUN ROAD NEW DISTRICT Suzhou, CN 215129 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen BIOCARE ASIA CORPORATION LTD. NO.260, MAYUN ROAD NEW DISTRICT Suzhou, CN 215129 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-28 |
| Decision Date | 2016-08-29 |