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)

LIDCO CNAP MODULE

K-Number: K131048 · 2013-08-28

ApplicantLidco, Ltd.
Decision Date2013-08-28
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIDCO CNAP MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Lidco, Ltd.. It received FDA 510(k) clearance on 2013-08-28 under 510(k) number K131048. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIDCO CNAP MODULE?

LIDCO CNAP MODULE is a medical device that received FDA 510(k) clearance on 2013-08-28. The listed applicant is Lidco, Ltd.. The 510(k) number is K131048.

When did LIDCO CNAP MODULE receive FDA 510(k) clearance?

LIDCO CNAP MODULE received FDA 510(k) clearance on 2013-08-28, under 510(k) number K131048.

Who is the listed applicant for LIDCO CNAP MODULE?

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

What is the FDA product code for LIDCO CNAP MODULE?

The FDA product code for LIDCO CNAP MODULE is DXG.

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 Lidco, Ltd. 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.

K163334LiDCOunity v2 Hemodynamic MonitorK152935LiDCOunity MonitorK122247LIDCORAPID V2 MONITORK023960LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70K010049PULSECO HEMODYNAMIC MONITOR CM71K962918LIDCO SYSTEM

View all 7 devices →

Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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.

↑