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)

CARDIOCALL CARDIAC EVENT RECORDER

K-Number: K972649 · 1997-12-04

ApplicantReynolds Medical , Ltd.
Decision Date1997-12-04
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOCALL CARDIAC EVENT RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Reynolds Medical , Ltd.. It received FDA 510(k) clearance on 1997-12-04 under 510(k) number K972649. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOCALL CARDIAC EVENT RECORDER?

CARDIOCALL CARDIAC EVENT RECORDER is a medical device that received FDA 510(k) clearance on 1997-12-04. The listed applicant is Reynolds Medical , Ltd.. The 510(k) number is K972649.

When did CARDIOCALL CARDIAC EVENT RECORDER receive FDA 510(k) clearance?

CARDIOCALL CARDIAC EVENT RECORDER received FDA 510(k) clearance on 1997-12-04, under 510(k) number K972649.

Who is the listed applicant for CARDIOCALL CARDIAC EVENT RECORDER?

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

What is the FDA product code for CARDIOCALL CARDIAC EVENT RECORDER?

The FDA product code for CARDIOCALL CARDIAC EVENT RECORDER is DXH. This falls under the Hematology category.

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 Reynolds Medical , 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.

K024283CARDIODIRECT, MODELS 12M, 12I, 12SK013367CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPHK011345CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEMK011837LIFECARD CF 7 DAYK001025LIFECARD CF COMPACT RECORDERK991211EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM

View all 12 devices →

Related Devices (Code: DXH)

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.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT 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.

↑