FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
K Number: K002604
·
Decision Feb 7, 2002
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
14
Review Days
534
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
- K Number
- K002604
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invivo Research, Inc.
- Date Received
- August 22, 2000
- Decision Date
- February 7, 2002
- Product Code
- DSI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSI), ordered by most recent decision date.
BodyGuardian Remote Monitoring System (BGRMS v3.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Zio AT® device (A100A1001)
FDA 510(k)
FDA Class 2
·Cardiovascular
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
FDA 510(k)
FDA Class 2
·Cardiovascular
SmartCardia 7L Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
Unified Arrhythmia Diagnostic System PocketECG IV
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Invivo Research, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050399 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 | Aug 26, 2005 | Substantially Equivalent |
| K043354 | MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 | Jan 10, 2005 | Substantially Equivalent |
| K041918 | INTEGRATED PATIENT MONITORING SYSTEM | Oct 15, 2004 | Substantially Equivalent |
| K040915 | MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M | Sep 22, 2004 | Substantially Equivalent |
| K002030 | OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES | Sep 26, 2000 | Substantially Equivalent |
| K980045 | CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM | Nov 16, 1998 | Substantially Equivalent |
| K974581 | MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT | Oct 28, 1998 | Substantially Equivalent |
| K971840 | OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM | Mar 4, 1998 | Substantially Equivalent |
| K955045 | OMNI-TRAK PATIENT MONITORING SYSTEM | Jul 11, 1996 | Substantially Equivalent |
| K945138 | OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS | Nov 20, 1995 | Substantially Equivalent |