Data / Medical devices / United States / Genia Medical, Inc.
Genia Medical, Inc.: FDA-registered device maker in Orlando, FL, United States, 1 510(k) clearance
Genia Medical, Inc. is registered with the FDA (registration 3004157007) in Orlando, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 13, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004157007
- Address
- 121 S Orange Ave Ste 1000 North, Orlando, FL, United States, 32801
- Owner or operator
- Genia Medical, Inc. (10051245)
- Roles
- Manufacturer for export, Specification developer
- First device listed
- February 22, 2016
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Holder, Syringe | IQG | 1 | Manufacturer for export | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | 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 |
|---|---|---|---|---|---|---|
| September 13, 2010 | K101380 | RXPEAKFLOW | BZH | Substantially Equivalent | Noble Marketing | accessdata.fda.gov |
Compare with other makers
Updated September 13, 2010. 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.