The following data is part of a premarket notification filed by Shenzhen Belter Health Measurement And Analysis Te with the FDA for Belter Infra-red Ear Thermometer.
| Device ID | K140681 |
| 510k Number | K140681 |
| Device Name: | BELTER INFRA-RED EAR THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE 702, 704 BLOCK C, TSINGHUA UNIS SCIENCE PARK NO. 13 LANGSHAN RD HI-TECH IND Shenzhen, Guangdong, CN 518057 |
| Contact | Pang Ming |
| Correspondent | Pang Ming SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE 702, 704 BLOCK C, TSINGHUA UNIS SCIENCE PARK NO. 13 LANGSHAN RD HI-TECH IND Shenzhen, Guangdong, CN 518057 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-18 |
| Decision Date | 2014-08-21 |
| Summary: | summary |
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|---|---|---|
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