Data / Medical devices / United States / Newman Medical
Newman Medical: FDA-registered device maker in Arvada, CO, United States, 2 510(k) clearances
Newman Medical is registered with the FDA (registration 3006265099) in Arvada, CO, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 12, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006265099
- Address
- 5350 Vivian Street Unit C, Arvada, CO, United States, 80002
- Owner or operator
- Newman Medical (9077121)
- Roles
- Manufacturer
- First device listed
- June 30, 2009
- Registered through
- 2026
- Brand names listed
- DigiDop II Ultrasound Systems, DigiDop Ultrasound Systems, simpleABI Ultrasound Systems
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Doppler, Fetal, Ultrasound | LXE | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Ultrasonic, Nonfetal | JAF | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 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 |
|---|---|---|---|---|---|---|
| May 12, 2011 | K110628 | SIMPLEABI | JAF | Substantially Equivalent | Newman Medical | accessdata.fda.gov |
| April 8, 2009 | K090465 | DIGDOP ULTRASOUND SYSTEM | ITX | Substantially Equivalent | The Newman Group, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 12, 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.