E-Picco Continuous Cardiac Output Module and Accessories
FDA 510(k) K132528 · GE Healthcare Finland Oy
510(k) numberK132528
Submission
- Device name
- E-Picco Continuous Cardiac Output Module and Accessories
- Applicant
- GE Healthcare Finland Oy
Helsinki, FI - Received
- August 12, 2013
- Decision date
- January 16, 2014
- 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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Questions and answers
When was E-Picco Continuous Cardiac Output Module and Accessories cleared by the FDA?
E-Picco Continuous Cardiac Output Module and Accessories (K132528) received a 510(k) decision of Substantially Equivalent on January 16, 2014, 157 days after the submission was received.
What is the product code of K132528?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.