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FDA 510(k)

EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM

K-Number: K991211 · 1999-07-08

ApplicantReynolds Medical , Ltd.
Decision Date1999-07-08
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM 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 1999-07-08 under 510(k) number K991211. 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 EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM?

EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM is a medical device that received FDA 510(k) clearance on 1999-07-08. The listed applicant is Reynolds Medical , Ltd.. The 510(k) number is K991211.

When did EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM receive FDA 510(k) clearance?

EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM received FDA 510(k) clearance on 1999-07-08, under 510(k) number K991211.

Who is the listed applicant for EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM?

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 EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM?

The FDA product code for EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM is DXH. This falls under the Hematology category.

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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 RECORDERK972649CARDIOCALL CARDIAC EVENT RECORDER

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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.

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