Data / Medical devices / United States / Zybs Consulting LLC Dba Zybs Medical Group, Dba Zybs Medical
Zybs Consulting LLC Dba Zybs Medical Group, Dba Zybs Medical: FDA-registered device maker in Largo, MD, United States, 1 510(k) clearance
Zybs Consulting LLC Dba Zybs Medical Group, Dba Zybs Medical is registered with the FDA (registration 3036999955) in Largo, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 22, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036999955
- Address
- 1401 Mercantile Ln Ste 381, Largo, MD, United States, 20774
- Owner or operator
- Zybs Consulting llc Dba Zybs Medical, Dba Zybs Medical Devic (10093047)
- Roles
- Repackager or relabeler
- First device listed
- March 21, 2025
- Registered through
- 2026
- Brand names listed
- Zybs Medical Upper Arm Electronic Blood Pressure Monitor Model: U80B
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 22, 2016 | K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 22, 2016. 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.