Data / Medical devices / United States / Strados Labs Inc.
Strados Labs Inc.: FDA-registered device maker in Marietta, GA, United States, 4 510(k) clearances
Strados Labs Inc. is registered with the FDA (registration 3026042935) in Marietta, GA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 18, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3026042935
- Address
- 1705 Enterprise Way Se Ste 102, Marietta, GA, United States, 30067
- Owner or operator
- Strados Labs Inc. (10084628)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 14, 2022
- Registered through
- 2027
- Brand names listed
- Nuvo Air, NuvoAir, RESP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Recorder, Magnetic Tape, Medical | DSH | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 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 |
|---|---|---|---|---|---|---|
| January 18, 2024 | K231416 | Air Next (NVD-02) | BZG | Substantially Equivalent | Nuvoair AB | accessdata.fda.gov |
| April 27, 2022 | K220893 | Strados Remote Electronic Stethoscope Platform (RESP) | DSH | Substantially Equivalent | Strados Labs, Inc. | accessdata.fda.gov |
| December 20, 2020 | K201077 | Strados Remote Electronic Stethoscope Platform (RESP) | DSH | Substantially Equivalent | Strados Labs | accessdata.fda.gov |
| January 2, 2020 | K183089 | Air Next | BZG | Substantially Equivalent | Nuvoair AB | accessdata.fda.gov |
Compare with other makers
Updated January 18, 2024. 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.