Data / Medical devices / United States / Aidar Health, Inc
Aidar Health, Inc: FDA-registered device maker in Columbia, MD, United States, 1 510(k) clearance
Aidar Health, Inc is registered with the FDA (registration 3023412068) in Columbia, MD, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 6, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023412068
- Address
- 7134 Columbia Gateway Dr Ste 150, Columbia, MD, United States, 21046
- Owner or operator
- Aidar Health, Inc (10086144)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 18, 2022
- Registered through
- 2026
- Brand names listed
- Aidar Health, MouthLab
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 |
|---|---|---|---|---|---|---|
| February 6, 2021 | K201635 | MouthLab Vital Signs Monitoring System | MWI | Substantially Equivalent | Multisensor Diagnostics (Dba Aidar Health) | accessdata.fda.gov |
Compare with other makers
- All makers of Meter, Peak Flow, Spirometry
- All makers of Monitor, Breathing Frequency
- All makers of Oximeter
- All makers of Electrocardiograph
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Continuous Measurement Thermometer
Updated February 6, 2021. 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.