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)

HEART ACCESS PLUS CARDIAC EVENT RECORDER

K-Number: K973141 · 1997-11-12

ApplicantPaceart, Inc.
Decision Date1997-11-12
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART ACCESS PLUS CARDIAC EVENT RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Paceart, Inc.. It received FDA 510(k) clearance on 1997-11-12 under 510(k) number K973141. 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 HEART ACCESS PLUS CARDIAC EVENT RECORDER?

HEART ACCESS PLUS CARDIAC EVENT RECORDER is a medical device that received FDA 510(k) clearance on 1997-11-12. The listed applicant is Paceart, Inc.. The 510(k) number is K973141.

When did HEART ACCESS PLUS CARDIAC EVENT RECORDER receive FDA 510(k) clearance?

HEART ACCESS PLUS CARDIAC EVENT RECORDER received FDA 510(k) clearance on 1997-11-12, under 510(k) number K973141.

Who is the listed applicant for HEART ACCESS PLUS CARDIAC EVENT RECORDER?

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

What is the FDA product code for HEART ACCESS PLUS CARDIAC EVENT RECORDER?

The FDA product code for HEART ACCESS PLUS 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 Paceart, 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.

K012407PACEART TX3 CARDIAC EVENT RECORDERK982090PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEMK960721PACEART WRIST ELECTRODESK952065PACEART CARDIOVOICEK931296PACEART CARDIOPHONEK915632PACEART CPTS-86/12

View all 9 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.

↑