Data / Medical devices / Singapore / Respiree Pte Ltd
Respiree Pte Ltd: FDA-registered device maker in Singapore Central Singapore, Singapore, 2 510(k) clearances
Respiree Pte Ltd is registered with the FDA (registration 3020277584) in Singapore Central Singapore, Singapore. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 5, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3020277584
- Address
- 23 Cantonment Road Singapore 089743, Singapore Central Singapore, Singapore, 089743
- Owner or operator
- Respiree PTE LTD (10087535)
- Roles
- Specification developer
- First device listed
- March 12, 2023
- Registered through
- 2027
- Brand names listed
- RESPIREE Cardio- respiratory Monitor System, RESPIREE Consumables for RS001.RPM, Respiree Cardio- respiratory System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Breathing Frequency | BZQ | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 5, 2025 | K250934 | Respiree Cardio- Respiratory Monitor System | BZQ | Substantially Equivalent | Respiree Pte, Ltd. | accessdata.fda.gov |
| March 8, 2023 | K223681 | Respiree Cardio-Respiratory Monitor | BZQ | Substantially Equivalent | Respiree Pte, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 5, 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.