8600 VITAL SIGNS MONITOR— 510(k) K042569
Substantially EquivalentCriticare Systems, Inc.
FDA 510(k) clearance K042569 for 8600 VITAL SIGNS MONITOR, Substantially Equivalent on 2004-09-29. Applicant: Criticare Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Criticare Systems, Inc.
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waukesha, WI, US
Recent devices under product code MWI
view allMore clearances from Criticare Systems, Inc.
view allAdverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K042569
K-number listed on FDA's recall record- Z-0810-2014 — Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.
- Z-1586-2013 — DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042569.
Data sourced from openFDA. This site is unofficial and independent of the FDA.