Transonic Costatus Cardiac Output System
FDA 510(k) K080116 · Transonic Systems, Inc.
510(k) numberK080116
Submission
- Device name
- Transonic Costatus Cardiac Output System
- Applicant
- Transonic Systems, Inc.
Ithaca, NY, US - Received
- January 16, 2008
- Decision date
- September 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K140740 | Transonic Tissue Perfusion MonitorDPW · Traditional | 07/23/2015SE |
| K134051 | Transonic Elsa SystemDXG · Traditional | 01/29/2015SE |
| K134035 | Transonic HCM 103 SystemDXG · Traditional | 09/17/2014SE |
| K140017 | Transonic HCM 102 SystemDXG · Traditional | 09/16/2014SE |
| K113821 | Transonic Costatus Cardiac Output SystemDXG · Traditional | 09/07/2012SE |
| K112657 | Aureflo Monitoring SystemDPW · Traditional | 12/21/2011SE |
| K033424 | Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter, Models…DPW · Special | 12/11/2003SE |
| K022963 | Transonic Syringe Warmer, Model SYR-1000MQS · Traditional | 12/04/2002SE |
| K021571 | Transonic Flow-Qc Set Model ADT1010MQS · Traditional | 08/12/2002SE |
| K010253 | Angio Flow Thermodilution Catheter, Model AF-CATH-01; Angioflow Meter, Models HQ100 and…DYG · Traditional | 03/19/2002SE |
Questions and answers
When was Transonic Costatus Cardiac Output System cleared by the FDA?
Transonic Costatus Cardiac Output System (K080116) received a 510(k) decision of Substantially Equivalent on September 8, 2008, 236 days after the submission was received.
What is the product code of K080116?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.