K250934
- 510(k) number
- K250934
- Device name
- Respiree Cardio- Respiratory Monitor System
- Applicant
- Respiree Pte, Ltd. SG
- Product code
- BZQ — Monitor, Breathing Frequency
- Decision date
- 2025-08-05
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250934.pdf
Official FDA record: K250934
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.