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FDA 510(k)

ACCUCOM CARDIAC OUTPUT MONITOR

K-Number: K851426 · 1985-07-12

ApplicantLawrence Medical Systems, Inc.
Decision Date1985-07-12
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCUCOM CARDIAC OUTPUT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Lawrence Medical Systems, Inc.. It received FDA 510(k) clearance on 1985-07-12 under 510(k) number K851426. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUCOM CARDIAC OUTPUT MONITOR?

ACCUCOM CARDIAC OUTPUT MONITOR is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Lawrence Medical Systems, Inc.. The 510(k) number is K851426.

When did ACCUCOM CARDIAC OUTPUT MONITOR receive FDA 510(k) clearance?

ACCUCOM CARDIAC OUTPUT MONITOR received FDA 510(k) clearance on 1985-07-12, under 510(k) number K851426.

Who is the listed applicant for ACCUCOM CARDIAC OUTPUT MONITOR?

The FDA 510(k) record lists Lawrence Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUCOM CARDIAC OUTPUT MONITOR?

The FDA product code for ACCUCOM CARDIAC OUTPUT MONITOR is DXK.

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 Lawrence Medical Systems, Inc. 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.

K874492LAWRENCE L4000 REFLECTANCE PULSE OXIMETERK874885LAWRENCE L3000 CARDIAC OUTPUT MONITORK862548TEMPERATURE SENSING ESOPHAGEAL TRANSDUCER

Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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