Data / Medical devices / Singapore / ResMed Asia Pte. Ltd.
ResMed Asia Pte. Ltd.: FDA-registered device maker in Singapore South West, Singapore, 2 510(k) clearances
ResMed Asia Pte. Ltd. is registered with the FDA (registration 3017684630) in Singapore South West, Singapore. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 24, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017684630
- Address
- 3 Tuas Avenue 2, Singapore South West, Singapore, 639443
- Owner or operator
- RESMED CORP. (9002319)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 18, 2004
- Registered through
- 2026
- Brand names listed
- AirFit F20, F20 QuietAir Elbow, Nightowl
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | 2 | Contract manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Contract manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Contract manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Contract manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Non-Life-Supporting | MNS | 2 | Contract manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 24, 2022 | K220028 | NightOwl | MNR | Substantially Equivalent | Ectosense NV | accessdata.fda.gov |
| December 10, 2010 | K102224 | PIXI PEDIATRIC MASK | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Continuous, Non-Life-Supporting
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Ventilatory Effort Recorder
- All makers of Generator, Oxygen, Portable
- All makers of Mask, Oxygen
- All makers of Set, Tubing And Support, Ventilator (W Harness)
Updated February 24, 2022. 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.