Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifeciences, LLC. It received FDA 510(k) clearance on 2022-11-07 under 510(k) 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. The listed applicant is Edwards Lifeciences, LLC. The 510(k) number is K223127.

When did HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable receive FDA 510(k) clearance?

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

Who is the listed applicant for HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable?

The FDA 510(k) record lists Edwards Lifeciences, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07148323HemoSphere Alta StudyRECRUITING

Other records listing Edwards Lifeciences, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - PressureK183413TruWave Disposable Pressure Transducer

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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.

↑