Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720
FDA 510(k) K013943 · Radi Medical Systems AB
510(k) numberK013943
Submission
- Device name
- Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720
- Applicant
- Radi Medical Systems AB
Uppsala, SE - Received
- November 29, 2001
- Decision date
- December 18, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSK – Computer, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1110
- Specialty
- Cardiovascular
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More from Florence Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K123984 | Quantien Measurement SystemDQK · Special | 03/28/2013SE |
| K092105 | Radianalyzer XpressDQK · Traditional | 10/09/2009SE |
| K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverDXO · Traditional | 07/01/2008SE |
| K080206 | Modification to Femostop Femoral Compression SystemDXC · Special | 02/26/2008SE |
| K062769 | Pressurewire Certus, Models 12006 and 12306DXO · Special | 12/04/2006SE |
| K042628 | Modification to: Radianalyzer, Model 12711DQK · Traditional | 01/19/2005SE |
| K033291 | Topseal Hemostatic Dressing, Model 11150QSY · Traditional | 03/17/2004SE |
| K031662 | Pressure Wire Sensor, Models 12004/12304DXO · Special | 06/06/2003SE |
| K024107 | Femostop Femoral Compression SystemDXC · Special | 12/24/2002SE |
| K022188 | Radianalyzer, Model 12710DQK · Traditional | 10/03/2002SE |
Questions and answers
When was Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720 cleared by the FDA?
Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720 (K013943) received a 510(k) decision of Substantially Equivalent on December 18, 2001, 19 days after the submission was received.
What is the product code of K013943?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.