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)

WIRELESS PHYSIOLOGIC MONITORING SYSTEM

K-Number: K053016 · 2005-12-30

ApplicantEdwards Lifesciences, LLC
Decision Date2005-12-30
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WIRELESS PHYSIOLOGIC MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2005-12-30 under 510(k) number K053016. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIRELESS PHYSIOLOGIC MONITORING SYSTEM?

WIRELESS PHYSIOLOGIC MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-30. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K053016.

When did WIRELESS PHYSIOLOGIC MONITORING SYSTEM receive FDA 510(k) clearance?

WIRELESS PHYSIOLOGIC MONITORING SYSTEM received FDA 510(k) clearance on 2005-12-30, under 510(k) number K053016.

Who is the listed applicant for WIRELESS PHYSIOLOGIC MONITORING SYSTEM?

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

What is the FDA product code for WIRELESS PHYSIOLOGIC MONITORING SYSTEM?

The FDA product code for WIRELESS PHYSIOLOGIC MONITORING SYSTEM is DXO.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Edwards Lifesciences, 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.

K251326Respiration Rate algorithmK253186HemoSphere Nano Monitor (HSNANO1)K251982Edwards MC3 Tricuspid annuloplasty ring (4900)K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)K242518Hypertension Prediction Index (HePI) AlgorithmK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

View all 122 devices →

Related Devices (Code: DXO)

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.

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLCK202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, Inc.

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.

↑