Flo Trac sensor, Volume View sensor
FDA 510(k) K152980 · Edwards Lifesciences, LLC
510(k) numberK152980
Submission
- Device name
- Flo Trac sensor, Volume View sensor
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- October 9, 2015
- Decision date
- January 19, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRS – Transducer, Blood-Pressure, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2850
- Specialty
- Cardiovascular
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Questions and answers
When was Flo Trac sensor, Volume View sensor cleared by the FDA?
Flo Trac sensor, Volume View sensor (K152980) received a 510(k) decision of Substantially Equivalent on January 19, 2016, 102 days after the submission was received.
What is the product code of K152980?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.