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 |