K233953
- 510(k) number
- K233953
- Device name
- Makani Science Respiration Monitoring System
- Applicant
- Makani Science, Inc. CA · US
- Product code
- BZQ — Monitor, Breathing Frequency
- Decision date
- 2025-03-28
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233953.pdf
Official FDA record: K233953
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.