Data / Medical devices / China / Dongguan Simzo Electronic Technology Co., Ltd.
Dongguan Simzo Electronic Technology Co., Ltd.: FDA-registered device maker in Dongguan Guangdong, China, 3 510(k) clearances
Dongguan Simzo Electronic Technology Co., Ltd. is registered with the FDA (registration 3015142935) in Dongguan Guangdong, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 27, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015142935
- Address
- No.6, Zhangzhou Road, Daojiao Town, Dongguan Guangdong, China, 523187
- Owner or operator
- Dongguan SIMZO Electronic Technology Co., Ltd. (10059316)
- Roles
- Manufacturer
- First device listed
- December 20, 2018
- Registered through
- 2026
- Brand names listed
- HW-1, HW-2, HW-2S, HW-3, HW-4, HW-4S, HW-302, HW-303, Infrared Forehead Thermometer HW-F1, HW-F2, HW-F3, HW-F4, HW-F5, HW-F6, HW-F7, HW-F8, HW-B05;, Infrared Thermometer, Infrared Thermometer HW-E01, HW-E02, HW-E03, HW-E04;, NBM-1, NBM-2, NBM-3, NBM-4, NBM-5, NBM-6, NBM-7, NBM-8, NBM-9, NBM-10, NBM-11, NBM-1C, NBM-2C, NBM-3C, NBM-4C, NBM-5C, NBM-6C, NBM-7C, NBM-8C, NBM-9C, NBM-10C, NBM-11C, NBM-3B, NBM-4B, NBM-5B, NBM-6B, NBM-7B, NBM-8B, NBM-9B, NBM-21B, NBM-10N and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2023 | K230379 | Portable (Ultrasonic) Nebulizer | CAF | Substantially Equivalent | Dongguan Simzo Electronic Technology Co., Ltd. | accessdata.fda.gov |
| September 3, 2021 | K211583 | Infrared Thermometer, Model: HW-1 | FLL | Substantially Equivalent | Dongguan Simzo Electronic Technology Co., Ltd. | accessdata.fda.gov |
| December 6, 2018 | K173048 | No-contact Forehead Thermometer | FLL | Substantially Equivalent | Dongguan Simzo Electronic Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Clinical Electronic Thermometer
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of Continuous Measurement Thermometer
Updated November 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.