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FDA 510(k)

EKG MONITORS, VARIOUS MODELS

K-Number: K820986 · 1982-04-29

ApplicantDart Medical Equipment
Decision Date1982-04-29
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EKG MONITORS, VARIOUS MODELS 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 1982-04-29 under 510(k) number K820986. 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 MONITORS, VARIOUS MODELS?

EKG MONITORS, VARIOUS MODELS is a medical device that received FDA 510(k) clearance on 1982-04-29. The listed applicant is Dart Medical Equipment. The 510(k) number is K820986.

When did EKG MONITORS, VARIOUS MODELS receive FDA 510(k) clearance?

EKG MONITORS, VARIOUS MODELS received FDA 510(k) clearance on 1982-04-29, under 510(k) number K820986.

Who is the listed applicant for EKG MONITORS, VARIOUS MODELS?

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 MONITORS, VARIOUS MODELS?

The FDA product code for EKG MONITORS, VARIOUS MODELS 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.

K820904EKG TELEPHONE CONVERTERK820828SAMMK803315CRITERION 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.

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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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