510(k) clearance
Sensinel Cardiopulmonary Management (CPM) System
- 510(k) number
- K260801
- Applicant
- Analog Devices
- Decision date
- Oct 16, 2026
- Date received
- Mar 11, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MWI
- Device type
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II
- Regulation
- 21 CFR 870.2300
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Wilmington, MA, US