OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS— 510(k) K945138
Substantially EquivalentInvivo Research, Inc.
FDA 510(k) clearance K945138 for OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS, Substantially Equivalent on 1995-11-20. Applicant: Invivo Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Invivo Research, Inc.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orlando, FL, US
Recent devices under product code DXN
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More clearances from Invivo Research, Inc.
view all- K050399 — MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160
- K043354 — MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
- 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 DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
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.