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)

CARDIOCAP(TM) DR-104 REPORTER

K-Number: K885058 · 1989-07-14

ApplicantDatex Division Instrumentarium Corp.
Decision Date1989-07-14
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOCAP(TM) DR-104 REPORTER is the device name listed in this FDA 510(k) record. The listed applicant is Datex Division Instrumentarium Corp.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K885058. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOCAP(TM) DR-104 REPORTER?

CARDIOCAP(TM) DR-104 REPORTER is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K885058.

When did CARDIOCAP(TM) DR-104 REPORTER receive FDA 510(k) clearance?

CARDIOCAP(TM) DR-104 REPORTER received FDA 510(k) clearance on 1989-07-14, under 510(k) number K885058.

Who is the listed applicant for CARDIOCAP(TM) DR-104 REPORTER?

The FDA 510(k) record lists Datex Division Instrumentarium Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOCAP(TM) DR-104 REPORTER?

The FDA product code for CARDIOCAP(TM) DR-104 REPORTER is DSF.

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 Datex Division Instrumentarium Corp. 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.

K953175AS/3 ESTPR MODULEK961247AS/3 LIGHT MONITORK943458AS/3 AIRWAY MODULEK945234AS/3 MEMORY MODULE, M0MEMK933156DATEX AS/3 PATIENT MONITORK933285DATEX AS/3 TM ANAESTHESIA MONITOR

View all 55 devices →

Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, 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.

↑