HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
FDA 510(k) K203687 · Edwards Lifesciences, LLC
510(k) numberK203687
Submission
- Device name
- HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- December 17, 2020
- Decision date
- May 28, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index cleared by the FDA?
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (K203687) received a 510(k) decision of Substantially Equivalent on May 28, 2021, 162 days after the submission was received.
What is the product code of K203687?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.