Data / Medical devices / United States / Apneicare, LLC
Apneicare, LLC: FDA-registered device maker in Columbus, OH, United States, 1 510(k) clearance
Apneicare, LLC is registered with the FDA (registration 3007799743) in Columbus, OH, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 2, 2009. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007799743
- Address
- 6185 Huntley Rd. Suite Q, Columbus, OH, United States, 43229
- Owner or operator
- ApneiCare, LLC (10030013)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 29, 2009
- Registered through
- 2027
- Brand names listed
- Patient Safety Connection Center, Patient Safety SatScreen, Patient Safety SleepScreen, SatCloud with Connection Center
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 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 |
|---|---|---|---|---|---|---|
| January 2, 2009 | K082968 | APNEICARE CONNECTION CENTER/INTERNET ANALYSIS | MNR | Substantially Equivalent | Apneicare, LLC | accessdata.fda.gov |
Compare with other makers
Updated January 2, 2009. 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.