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FDA 510(k)

DIGITAL MEDICINE ECG MONITOR AND RECORDER

K-Number: K880971 · 1988-08-30

ApplicantDigital Medicine Systems
Decision Date1988-08-30
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL MEDICINE ECG MONITOR AND RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Digital Medicine Systems. It received FDA 510(k) clearance on 1988-08-30 under 510(k) number K880971. 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 MEDICINE ECG MONITOR AND RECORDER?

DIGITAL MEDICINE ECG MONITOR AND RECORDER is a medical device that received FDA 510(k) clearance on 1988-08-30. The listed applicant is Digital Medicine Systems. The 510(k) number is K880971.

When did DIGITAL MEDICINE ECG MONITOR AND RECORDER receive FDA 510(k) clearance?

DIGITAL MEDICINE ECG MONITOR AND RECORDER received FDA 510(k) clearance on 1988-08-30, under 510(k) number K880971.

Who is the listed applicant for DIGITAL MEDICINE ECG MONITOR AND RECORDER?

The FDA 510(k) record lists Digital Medicine Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL MEDICINE ECG MONITOR AND RECORDER?

The FDA product code for DIGITAL MEDICINE ECG MONITOR AND RECORDER 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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