Modular Telemetry System for the Vision Telepak, Model 20701
FDA 510(k) K043354 · Invivo Research, Inc.
510(k) numberK043354
Submission
- Device name
- Modular Telemetry System for the Vision Telepak, Model 20701
- Applicant
- Invivo Research, Inc.
Orlando, FL, US - Received
- December 6, 2004
- Decision date
- January 10, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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| K050399 | MRI Compatible Patient Monitoring System, Model 3160MWI · Traditional | 08/26/2005SE |
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| 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 |
| K002030 | Omni-Trak 3150/3155A Series Monitor with Anesthetic Agent, Model 3155A SeriesMWI · Traditional | 09/26/2000SE |
| 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 Modular Telemetry System for the Vision Telepak, Model 20701 cleared by the FDA?
Modular Telemetry System for the Vision Telepak, Model 20701 (K043354) received a 510(k) decision of Substantially Equivalent on January 10, 2005, 35 days after the submission was received.
What is the product code of K043354?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.