K231086
- 510(k) number
- K231086
- Device name
- CPM System
- Applicant
- Analog Devices, Inc. MA · US
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2023-12-22
- Date received
- 2023-04-17
- 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: K231086
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.