Device type
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Product code MWI · Class II · 21 CFR 870.2300 · Cardiovascular
Recent 510(k)s
Oct 16, 2026
K260801
Sensinel Cardiopulmonary Management (CPM) System
Analog Devices
- MWI
- Class II
Recent recalls
Sep 30, 2026
Z-3220-2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturatio…
Midmark Corporation
- MWI
- Class II
- Ongoing
Sep 30, 2026
Z-3218-2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturatio…
Midmark Corporation
- MWI
- Class II
- Ongoing
Sep 30, 2026
Z-3219-2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturatio…
Midmark Corporation
- MWI
- Class II
- Ongoing
Sep 30, 2026
Z-3217-2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturatio…
Midmark Corporation
- MWI
- Class II
- Ongoing
Sep 2, 2026
Z-3038-2026
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
GE Medical Systems Information Technologies Inc
- MWI
- Class II
- Ongoing
Sep 2, 2026
Z-3037-2026
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
GE Medical Systems Information Technologies Inc
- MWI
- Class II
- Ongoing
Sep 2, 2026
Z-3039-2026
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
GE Medical Systems Information Technologies Inc
- MWI
- Class II
- Ongoing
Sep 2, 2026
Z-3036-2026
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
GE Medical Systems Information Technologies Inc
- MWI
- Class II
- Ongoing