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FDA 510(k)

EKG TELEPHONE CONVERTER

K-Number: K820904 · 1982-04-21

ApplicantDart Medical Equipment
Decision Date1982-04-21
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EKG TELEPHONE CONVERTER is the device name listed in this FDA 510(k) record. The listed applicant is Dart Medical Equipment. It received FDA 510(k) clearance on 1982-04-21 under 510(k) number K820904. 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 EKG TELEPHONE CONVERTER?

EKG TELEPHONE CONVERTER is a medical device that received FDA 510(k) clearance on 1982-04-21. The listed applicant is Dart Medical Equipment. The 510(k) number is K820904.

When did EKG TELEPHONE CONVERTER receive FDA 510(k) clearance?

EKG TELEPHONE CONVERTER received FDA 510(k) clearance on 1982-04-21, under 510(k) number K820904.

Who is the listed applicant for EKG TELEPHONE CONVERTER?

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

What is the FDA product code for EKG TELEPHONE CONVERTER?

The FDA product code for EKG TELEPHONE CONVERTER is DXH. This falls under the Hematology category.

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Other records listing Dart Medical Equipment 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.

K820986EKG MONITORS, VARIOUS MODELSK820828SAMMK803315CRITERION II RHYTHM PROFILE MONITORK802782THE CRITERION II PACING SYS. MONITORK802325CRITERION II PACING SYSTEM MONITORSK800286CRITERION II PACING SYSTEM MONITORS

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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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