K260579
- 510(k) number
- K260579
- Device name
- Infinity® Acute Care System (IACS) VG8.1
- Applicant
- Draeger Medical Systems, Inc. MA · US
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2026-08-20
- Date received
- 2026-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K260579.pdf
Official FDA record: K260579
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.