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FDA 510(k)

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

K-Number: K223127 · 2022-11-07

ApplicantEdwards Lifeciences, LLC
Decision Date2022-11-07
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable is a medical device manufactured by Edwards Lifeciences, LLC. It received FDA 510(k) clearance on 2022-11-07 under approval number K223127. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable?

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable is a medical device that received FDA 510(k) clearance on 2022-11-07. It is manufactured by Edwards Lifeciences, LLC. The 510(k) number is K223127.

When was HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable approved by the FDA?

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable received FDA 510(k) clearance on 2022-11-07, under approval number K223127.

What company makes HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable?

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable is manufactured by Edwards Lifeciences, LLC.

What is the FDA product code for HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable?

The FDA product code for HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable is DQK.

Related Clinical Trials

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Related PubMed Literature

PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025)

Other Devices by Edwards Lifeciences, LLC

K183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure K183413TruWave Disposable Pressure Transducer

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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