MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160— 510(k) K050399
Substantially EquivalentInvivo Research, Inc.
FDA 510(k) clearance K050399 for MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160, Substantially Equivalent on 2005-08-26. Applicant: Invivo Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Invivo Research, 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
- Traditional
- Location
- Orlando, FL, US
Recent devices under product code MWI
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- K041918 — INTEGRATED PATIENT MONITORING SYSTEM
- K040915 — MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
- K002604 — CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
- K002030 — OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.