The following data is part of a premarket notification filed by Nexmed Technology Co., Ltd with the FDA for Infrared Thermometer (model: Lx-26e, Lx-260te, Pro Lx-261e, Lx-360, Lx-361t, Bw-cx10).
| Device ID | K160816 |
| 510k Number | K160816 |
| Device Name: | Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | NEXMED TECHNOLOGY CO., LTD 2 FLOOR OF NO.1 BUILDING, JIA AN TECHNOLOGICAL INDUSTRIAL PARK, 67 DISTRICT Shenzhen, CN 518000 |
| Contact | Ellen Xu |
| Correspondent | Elena Lu SHENZHEN JOYANTECH CONSULTING CO., LTD. ROOM 1122, INTERNATIONAL MAYORS COMMUNICATION CENTRE Shenzhen, CN 518101 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-24 |
| Decision Date | 2016-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973127140024 | K160816 | 000 |
| 03760165447474 | K160816 | 000 |
| 03760165447467 | K160816 | 000 |
| 03760165447429 | K160816 | 000 |
| 03760165446408 | K160816 | 000 |
| 03760165440291 | K160816 | 000 |
| 03700609705142 | K160816 | 000 |
| 03700609705135 | K160816 | 000 |
| 03700609705128 | K160816 | 000 |
| 03700609705111 | K160816 | 000 |
| 03700609705104 | K160816 | 000 |
| 03760165447481 | K160816 | 000 |
| 03760165448242 | K160816 | 000 |
| 00872320004941 | K160816 | 000 |
| 00846127199377 | K160816 | 000 |
| 06973127140031 | K160816 | 000 |
| 06973399670014 | K160816 | 000 |
| 03760165449843 | K160816 | 000 |
| 03760165449836 | K160816 | 000 |
| 03760165449492 | K160816 | 000 |
| 03760165449485 | K160816 | 000 |
| 03760165449478 | K160816 | 000 |
| 03760165448259 | K160816 | 000 |
| 03700609705098 | K160816 | 000 |