Data / Medical devices / United States / Apn Health Inc
Apn Health Inc: FDA-registered device maker in Brookfield, WI, United States, 1 510(k) clearance
Apn Health Inc is registered with the FDA (registration 3014282601) in Brookfield, WI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 23, 2016. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014282601
- Address
- 280 Regency Ct Fl 2, Brookfield, WI, United States, 53045
- Owner or operator
- APN Health LLC (10056873)
- Roles
- Manufacturer
- First device listed
- January 25, 2018
- Registered through
- 2027
- Brand names listed
- Navik 3D SaMD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 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 |
|---|---|---|---|---|---|---|
| February 23, 2016 | K152160 | Navik 3D | DQK | Substantially Equivalent | Apn Health, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 7, 2023 | 93419 | Class III | Completed | Navik 3D v2, REF NAVIK3D, 3D Mapping System | IFU update | accessdata.fda.gov |
Compare with other makers
Updated December 14, 2023. 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.