Data / Medical devices / Australia / Atmo Biosciences Ltd
Atmo Biosciences Ltd: FDA-registered device maker in Box Hill Victoria, Australia, 1 510(k) clearance
Atmo Biosciences Ltd is registered with the FDA (registration 3027568582) in Box Hill Victoria, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 26, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027568582
- Address
- 436 Elgar Rd, Box Hill Victoria, Australia, 3128
- Owner or operator
- Atmo Biosciences Ltd (10093741)
- Roles
- Manufacturer
- First device listed
- July 1, 2025
- Registered through
- 2026
- Brand names listed
- Atmo Gas Capsule System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gastrointestinal Motility System, Capsule | NYV | 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 |
|---|---|---|---|---|---|---|
| June 26, 2025 | K250940 | Atmo Gas Capsule System | NYV | Substantially Equivalent | Atmo Biosciences, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 26, 2025. 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.