Omni-Trak 3150/3155A Series Monitor with Anesthetic Agent, Model 3155A Series
FDA 510(k) K002030 · Invivo Research, Inc.
510(k) numberK002030
Submission
- Device name
- Omni-Trak 3150/3155A Series Monitor with Anesthetic Agent, Model 3155A Series
- Applicant
- Invivo Research, Inc.
Orlando, FL, US - Received
- July 3, 2000
- Decision date
- September 26, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
More from Welch Allyn, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K050399 | MRI Compatible Patient Monitoring System, Model 3160MWI · Traditional | 08/26/2005SE |
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| K041918 | Integrated Patient Monitoring SystemMWI · Traditional | 10/15/2004SE |
| K040915 | Magnitude 3150M MRI Patient Monitor, Model 3150MMWI · Traditional | 09/22/2004SE |
| K002604 | Centurion 2000 Central Station Arrhythmia Patient Monitoring SystemDSI · Traditional | 02/07/2002SE |
| K980045 | Centurion Central Station Arrhythmia Patient Monitoring SystemDSI · Traditional | 11/16/1998SE |
| K974581 | Millennia 3500 Series Monitor with Anthesthetic AgentDRT · Traditional | 10/28/1998SE |
| K971840 | Omni-Trak Model 3150 Series Patient Monitoring SystemMHX · Traditional | 03/04/1998SE |
| K955045 | Omni-Trak Patient Monitoring SystemDPS · Traditional | 07/11/1996SE |
| K945138 | Omega 5600 Series Non-Invasive Blood Pressure MonitorsDXN · Traditional | 11/20/1995SE |
Questions and answers
When was Omni-Trak 3150/3155A Series Monitor with Anesthetic Agent, Model 3155A Series cleared by the FDA?
Omni-Trak 3150/3155A Series Monitor with Anesthetic Agent, Model 3155A Series (K002030) received a 510(k) decision of Substantially Equivalent on September 26, 2000, 85 days after the submission was received.
What is the product code of K002030?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.