Data / Medical devices / Singapore / Amt Pte. Ltd.
Amt Pte. Ltd.: FDA-registered device maker in Singapore South West, Singapore, 3 510(k) clearances
Amt Pte. Ltd. is registered with the FDA (registration 3009987158) in Singapore South West, Singapore. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated April 8, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009987158
- Address
- 3 Tuas Lane, Singapore South West, Singapore, 638612
- Owner or operator
- AMT PTE. LTD. (10079864)
- Roles
- Manufacturer
- First device listed
- December 29, 2020
- Registered through
- 2027
- Brand names listed
- BiWaze Clear System, BiWaze Cough
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Positive Pressure Breathing, Intermittent | NHJ | 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 |
|---|---|---|---|---|---|---|
| April 8, 2024 | K231728 | BiWaze Clear System | NHJ | Substantially Equivalent | Abmrc, LLC | accessdata.fda.gov |
| December 21, 2022 | K213564 | BiWaze Clear System | NHJ | Substantially Equivalent | Abmrc, LLC | accessdata.fda.gov |
| March 27, 2020 | K191912 | BiWaze Cough | NHJ | Substantially Equivalent | Abmrc, LLC | accessdata.fda.gov |
Compare with other makers
Updated April 8, 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.