The following data is part of a premarket notification filed by Biocare Asia Corporation Ltd. with the FDA for Fora Diamond Nexus Mini Infrared Forehead Thermometer.
| Device ID | K132457 |
| 510k Number | K132457 |
| Device Name: | FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | BIOCARE ASIA CORPORATION LTD. NO. 260, MAYUN ROAD New District Suzhou, CN 215129 |
| Contact | Shuchi Chang |
| Correspondent | Shuchi Chang 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 | 2013-08-06 |
| Decision Date | 2014-02-21 |
| Summary: | summary |