K260438
- 510(k) number
- K260438
- Device name
- Vital Signs Monitor (CLEO2)
- Applicant
- Infinium Medical, Inc. FL · US
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2026-08-14
- Date received
- 2026-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K260438
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.