CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM— 510(k) K002604
Substantially EquivalentInvivo Research, Inc.
FDA 510(k) clearance K002604 for CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM, Substantially Equivalent on 2002-02-07. 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
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- K041918 — INTEGRATED PATIENT MONITORING SYSTEM
- K040915 — MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M
- K002030 — OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
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.