OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM— 510(k) K971840
Substantially EquivalentInvivo Research, Inc.
FDA 510(k) clearance K971840 for OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM, Substantially Equivalent on 1998-03-04. Applicant: Invivo Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Invivo Research, Inc.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orlando, FL, US
Recent devices under product code MHX
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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
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
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.