K250093
- 510(k) number
- K250093
- Device name
- Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
- Applicant
- Linshom Medical, Inc. MD · US
- Product code
- BZQ — Monitor, Breathing Frequency
- Decision date
- 2025-09-26
- Date received
- 2025-01-14
- 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: K250093.pdf
Official FDA record: K250093
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.