Bio Z Cardio Profile Hemodynamic Monitor
FDA 510(k) K110645 · Sonosite,Inc.
510(k) numberK110645
Submission
- Device name
- Bio Z Cardio Profile Hemodynamic Monitor
- Applicant
- Sonosite,Inc.
Bothell, WA, US - Received
- March 4, 2011
- Decision date
- June 3, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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More from Zynex Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K113156 | Sonosite Edge Ultrasound SystemIYO · Traditional | 11/15/2011SE |
| K102390 | Sonosite Nanomaxx Series Ultrasound SystemIYN · Traditional | 11/19/2010SE |
| K093510 | Lumenvu Catheter Guidance SystemOMF · Traditional | 08/23/2010SE |
| K101757 | Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemITX · Traditional | 08/12/2010SE |
| K092058 | Sonosite Nanomaxx Series Ultrasound SystemIYN · Traditional | 10/02/2009SE |
| K082098 | Sonosite Maxx Series Ultrasound SystemIYN · Traditional | 08/25/2008SE |
| K071134 | Sonosite Maxx Series Diagnostic Ultrasound SystemIYO · Traditional | 05/08/2007SE |
| K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)IYN · Traditional | 11/16/2005SE |
| K052109 | Sonosite Hand-Carried Ultrasound System (C1 Series)IYN · Traditional | 08/11/2005SE |
| K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)IYN · Traditional | 01/12/2005SE |
Questions and answers
When was Bio Z Cardio Profile Hemodynamic Monitor cleared by the FDA?
Bio Z Cardio Profile Hemodynamic Monitor (K110645) received a 510(k) decision of Substantially Equivalent on June 3, 2011, 91 days after the submission was received.
What is the product code of K110645?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.