FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
K Number: K002030
·
Decision Sep 26, 2000
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
14
Review Days
85
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Basic Information
- Device Name
- OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
- K Number
- K002030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invivo Research, Inc.
- Date Received
- July 3, 2000
- Decision Date
- September 26, 2000
- Product Code
- MWI
- 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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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 |
| K002604 | CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM | Feb 7, 2002 | 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 |