Data / Medical devices / Abnormal breath sound device
FDA registered abnormal breath sound device manufacturers: 3 in 3 countries
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Updated September 25, 2026. Source: openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files).
There are 3 FDA registered manufacturers of abnormal breath sound devices in 3 countries (product code PHZ, Class 2, 21 CFR 868.1900). Each row gives the establishment, its city, its FDA registration number, its role, and its 510(k) clearances, PMA approvals and recalls for this device. 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on September 25, 2026, and lists 0 recall events (0 Class I). FDA data exported November 9, 2026.
The request: Every FDA registered manufacturer of abnormal breath sound devices worldwide, by country, with its 510(k) clearances, PMA approvals and recalls. $10 of credit on sign-up, no card.
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- Product code
- PHZ
- FDA device name
- Abnormal Breath Sound Device
- Device class
- 2
- Regulation
- 868.1900
- Medical specialty
- Anesthesiology
Manufacturers by country
| Country | Manufacturers |
|---|---|
| Israel | 1 |
| Singapore | 1 |
| Australia | 1 |
Manufacturers of abnormal breath sound devices
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Manufacturer | Location | FDA registration | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|---|
| Tytocare Ltd. | Netanya Central, Israel | 3012678246 | Manufacturer | 5 | June 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Aevice Health Pte. Ltd. | Singapore North East, Singapore | 3042167640 | Complaint file establishment, Manufacturer | 1 | September 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Vitasora Health Limited | Melbourne Victoria, Australia | 3021974922 | Specification developer | 1 | March 11, 2021 | 0 | 0 | 0 | api.fda.gov |
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. FDA registration lists an establishment with the FDA and is not an approval of it: a 510(k) clearance or a PMA approval is for one device. 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.