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)

CARDIO IV/GXT STRESS TESTING SYSTEM

K-Number: K844744 · 1985-01-23

ApplicantIntl. Medical, Inc.
Decision Date1985-01-23
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO IV/GXT STRESS TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical, Inc.. It received FDA 510(k) clearance on 1985-01-23 under 510(k) number K844744. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO IV/GXT STRESS TESTING SYSTEM?

CARDIO IV/GXT STRESS TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1985-01-23. The listed applicant is Intl. Medical, Inc.. The 510(k) number is K844744.

When did CARDIO IV/GXT STRESS TESTING SYSTEM receive FDA 510(k) clearance?

CARDIO IV/GXT STRESS TESTING SYSTEM received FDA 510(k) clearance on 1985-01-23, under 510(k) number K844744.

Who is the listed applicant for CARDIO IV/GXT STRESS TESTING SYSTEM?

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

What is the FDA product code for CARDIO IV/GXT STRESS TESTING SYSTEM?

The FDA product code for CARDIO IV/GXT STRESS TESTING SYSTEM is DPS.

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 Intl. Medical, 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.

K970507PEAK FLOW METERK943078HOT BIOPSY FORCEPSK940370AMERICAN CATHETER E.R.C.P. CANNULAK940335AMERICAN CATHETER POLY-SNAREK942068AMERICAN CATHETER SPHINCTEROTOMEK930410DURHAM; LUER LOCK EXTENSION SET

View all 17 devices →

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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.

↑