The following data is part of a premarket notification filed by Dongguan Simzo Electronic Technology Co.ltd. with the FDA for Infrared Thermometer, Model: Hw-1.
| Device ID | K211583 |
| 510k Number | K211583 |
| Device Name: | Infrared Thermometer, Model: HW-1 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Dongguan SIMZO Electronic Technology Co.Ltd. No. 6 Zhangzhou Road, Daojiao Town Dongguan, CN 523187 |
| Contact | Jinlong Wang |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co. Room 1813#, Gebu Commercial Building, Hongxing Community, Songgang Street Shenzhen, CN 518000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-24 |
| Decision Date | 2021-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810021171180 | K211583 | 000 |
| 00810021171173 | K211583 | 000 |
| G018P850DC1 | K211583 | 000 |