K243183
- 510(k) number
- K243183
- Device name
- RTMsense Respiratory Monitoring System
- Applicant
- Rtm Vital Signs, LLC PA · US
- Product code
- BZQ — Monitor, Breathing Frequency
- Decision date
- 2025-06-27
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243183.pdf
Official FDA record: K243183
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.