Transonic Syringe Warmer, Model SYR-1000
FDA 510(k) K022963 · Transonic Systems, Inc.
510(k) numberK022963
Submission
- Device name
- Transonic Syringe Warmer, Model SYR-1000
- Applicant
- Transonic Systems, Inc.
Ithaca, NY, US - Received
- September 6, 2002
- Decision date
- December 4, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQS – System, Hemodialysis, Access Recirculation Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K021571 | Transonic Flow-Qc Set Model ADT1010MQS · Traditional | Transonic Systems, Inc. | 08/12/2002SE |
| K001763 | Crit-Line Monitor III (CLM III)MQS · Traditional | In-Line Diagnostics Corp. | 12/20/2000SE |
| K993587 | HP M2376A Device Link SystemMQS · Traditional | Hewlett-Packard Co. | 01/20/2000SE |
| K992227 | Crit-Line Monitor III (CLM III)MQS · Special | In-Line Diagnostics Corp. | 07/30/1999SE |
| K984194 | HP M2376A Device Link SystemMQS · Traditional | Hewlett-Packard Co. | 04/30/1999SE |
| K982412 | Modification of Crit-Line Monitor III (CLM III)MQS · Traditional | In-Line Diagnostics Corp. | 10/09/1998SE |
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| 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 |
| K080116 | Transonic Costatus Cardiac Output SystemDXG · Traditional | 09/08/2008SE |
| K033424 | Angioflow Meter, Angioflow Antegrade Catheter, Angioflow Retrograde Catheter, Models…DPW · Special | 12/11/2003SE |
| 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 Syringe Warmer, Model SYR-1000 cleared by the FDA?
Transonic Syringe Warmer, Model SYR-1000 (K022963) received a 510(k) decision of Substantially Equivalent on December 4, 2002, 89 days after the submission was received.
What is the product code of K022963?
The FDA product code is MQS – System, Hemodialysis, Access Recirculation Monitoring, a Class II (moderate risk) device regulated under 21 CFR 876.5820.