Data / Medical devices / China / Suzhou Melodicare Medical Technology Co., Ltd
Suzhou Melodicare Medical Technology Co., Ltd: FDA-registered device maker in Suzhou Jiangsu, China, 3 510(k) clearances
Suzhou Melodicare Medical Technology Co., Ltd is registered with the FDA (registration 3016864576) in Suzhou Jiangsu, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 18, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016864576
- Address
- Room 301, Building F2, No. 32 Hongxi road, Suzhou high-tech zone,Jiangsu province., Suzhou Jiangsu, China, 215000
- Owner or operator
- Suzhou Melodicare Medical Technology Co., Ltd (10069005)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 11, 2020
- Registered through
- 2026
- Brand names listed
- Electronic Stethoscope,model:iSteso-D2, Electronic Stethoscope,model:smartho-D2, Infrared Thermometer, model Breeze, Infrared Thermometer, model Breeze-20, Surgical Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US | accessdata.fda.gov |
| Stethoscope, Electronic | DQD | 2 | 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 |
|---|---|---|---|---|---|---|
| December 18, 2019 | K191667 | Electronic Stethoscope | DQD | Substantially Equivalent | Hefei Mintti Medical Technology Co., Ltd. China | accessdata.fda.gov |
| October 18, 2019 | K191283 | Infrared Thermometer, Breeze model | FLL | Substantially Equivalent | Suzhou Melodicare Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 23, 1977 | K770463 | MASK, SURGICAL, FACE, DISPOSABLE | FXX | Substantially Equivalent | Precept, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Stethoscope, Electronic
- All makers of Mask, Surgical
Updated December 18, 2019. 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.