K243216
- 510(k) number
- K243216
- Device name
- Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
- Applicant
- Analog Devices MA · US
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2024-12-10
- Date received
- 2024-10-03
- 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: K243216
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.