K240312
- 510(k) number
- K240312
- Device name
- Infinity CentralStation Wide
- Applicant
- Draeger Medical Systems, Inc. MA · US
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2024-08-01
- Date received
- 2024-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240312.pdf
Official FDA record: K240312
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.