CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM— 510(k) K980045
Substantially EquivalentInvivo Research, Inc.
FDA 510(k) clearance K980045 for CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM, Substantially Equivalent on 1998-11-16. Applicant: Invivo Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Invivo Research, Inc.
- Product code
- Code DSI
- 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 DSI
view allMore 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 DSI
product code DSI- Death
- 170
- Injury
- 729
- Malfunction
- 10,680
- Total
- 11,579
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.