K231477
- 510(k) number
- K231477
- Device name
- Infinity CentralStation Wide, Infinity M300, Infinity M300+
- Applicant
- Draeger Medical Systems, Inc. MA · US
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2023-10-17
- Date received
- 2023-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K231477.pdf
Official FDA record: K231477
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.