Data / Medical devices / Israel / Pulmone Advanced Medical Devices, Ltd.
Pulmone Advanced Medical Devices, Ltd.: FDA-registered device maker in Raananna Central, Israel, 2 510(k) clearances
Pulmone Advanced Medical Devices, Ltd. is registered with the FDA (registration 3011269086) in Raananna Central, Israel. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 21, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011269086
- Address
- 14 HaMelacha Street, Raananna Central, Israel, 4366107
- Owner or operator
- PulmOne Advanced Medical Devices, Ltd. (10049235)
- Roles
- Manufacturer
- First device listed
- May 1, 2015
- Registered through
- 2026
- Brand names listed
- MiniBox, MiniBox+
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Pulmonary Function Data | BZC | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 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 |
|---|---|---|---|---|---|---|
| October 21, 2016 | K161295 | MiniBox + | BZC | Substantially Equivalent | Pulmone Advanced Medical Devices, Ltd. | accessdata.fda.gov |
| March 6, 2015 | K141793 | PULMONE MINIBOXPFT 2.0 | BZG | Substantially Equivalent | Pulmone Advanced Medical Devices, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 21, 2016. 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.