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FDA 510(k)

DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM

K-Number: K892370 · 1989-08-28

ApplicantBio-Focus, Inc.
Decision Date1989-08-28
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Focus, Inc.. It received FDA 510(k) clearance on 1989-08-28 under 510(k) number K892370. 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 DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM?

DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-08-28. The listed applicant is Bio-Focus, Inc.. The 510(k) number is K892370.

When did DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM receive FDA 510(k) clearance?

DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM received FDA 510(k) clearance on 1989-08-28, under 510(k) number K892370.

Who is the listed applicant for DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM?

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

What is the FDA product code for DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM?

The FDA product code for DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM is DXH. This falls under the Hematology category.

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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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