Aureflo Monitoring System
FDA 510(k) K112657 · Transonic Systems, Inc.
510(k) numberK112657
Submission
- Device name
- Aureflo Monitoring System
- Applicant
- Transonic Systems, Inc.
Ithaca, NY, US - Received
- September 13, 2011
- Decision date
- December 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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| K140740 | Transonic Tissue Perfusion MonitorDPW · Traditional | 07/23/2015SE |
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| K140017 | Transonic HCM 102 SystemDXG · Traditional | 09/16/2014SE |
| K113821 | Transonic Costatus Cardiac Output SystemDXG · Traditional | 09/07/2012SE |
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| 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 Aureflo Monitoring System cleared by the FDA?
Aureflo Monitoring System (K112657) received a 510(k) decision of Substantially Equivalent on December 21, 2011, 99 days after the submission was received.
What is the product code of K112657?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.