The following data is part of a premarket notification filed by Shenzhen Everbest Machinery Industry Co., Ltd. with the FDA for Non-contact Forehead Infrared Thermometer, Model Dt-8806h, Body Infrared Thermometer, Model Dt-8806 And Digital Infrared.
| Device ID | K101736 |
| 510k Number | K101736 |
| Device Name: | NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD. 19TH BUILDING, 5TH REGION BAIWANGXIN IND. PK. SONGBAI RD Baimang Xili Nanshan Shenzhen, CN |
| Contact | Deng Aiguo |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-21 |
| Decision Date | 2010-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06951110988365 | K101736 | 000 |
| 06951110988259 | K101736 | 000 |
| 06951110980062 | K101736 | 000 |