Data / Medical devices / China / Sonitus Medical (shanghai) Co., Ltd.
Sonitus Medical (shanghai) Co., Ltd.: FDA-registered device maker in shanghai, China, 2 510(k) clearances
Sonitus Medical (shanghai) Co., Ltd. is registered with the FDA (registration 3014990990) in shanghai, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 21, 2011. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014990990
- Address
- Floor 5, Bldg. 11 & Floor 4-5, Bldg. 7, 500 Furonghua Rd, Pudong, Shanghai, shanghai, China, 201318
- Owner or operator
- Sonitus Medical (Shanghai) Co., Ltd. (10060074)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 27, 2019
- Registered through
- 2026
- Brand names listed
- SoundBite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hearing Aid, Bone Conduction | LXB | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 21, 2011 | K110831 | SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL | LXB | Substantially Equivalent | Sonitus Medical, Inc. | accessdata.fda.gov |
| January 14, 2011 | K100649 | SOUNDBITE HEARING SYSTEM BY SONITUS | LXB | Substantially Equivalent | Sonitus Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 21, 2011. 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.