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)

CARDIOSENTRY EVENT MONITOR, MODEL 8470-01

K-Number: K001634 · 2000-12-21

ApplicantTz Medical, Inc.
Decision Date2000-12-21
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 is the device name listed in this FDA 510(k) record. The listed applicant is Tz Medical, Inc.. It received FDA 510(k) clearance on 2000-12-21 under 510(k) number K001634. 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 CARDIOSENTRY EVENT MONITOR, MODEL 8470-01?

CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 is a medical device that received FDA 510(k) clearance on 2000-12-21. The listed applicant is Tz Medical, Inc.. The 510(k) number is K001634.

When did CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 receive FDA 510(k) clearance?

CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 received FDA 510(k) clearance on 2000-12-21, under 510(k) number K001634.

Who is the listed applicant for CARDIOSENTRY EVENT MONITOR, MODEL 8470-01?

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

What is the FDA product code for CARDIOSENTRY EVENT MONITOR, MODEL 8470-01?

The FDA product code for CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 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 Tz 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.

K252772Arc Adjustable Radial Cuff Compression DeviceK173563ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICEK163322TZ SKULL PIN AdultK102507AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTORK062577V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPCK040208NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND

View all 15 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.

↑