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FDA 510(k)

EKG TRANSMITTER MODEL 5134

K-Number: K842051 · 1985-03-01

ApplicantInstromedix, Inc.
Decision Date1985-03-01
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EKG TRANSMITTER MODEL 5134 is the device name listed in this FDA 510(k) record. The listed applicant is Instromedix, Inc.. It received FDA 510(k) clearance on 1985-03-01 under 510(k) number K842051. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKG TRANSMITTER MODEL 5134?

EKG TRANSMITTER MODEL 5134 is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Instromedix, Inc.. The 510(k) number is K842051.

When did EKG TRANSMITTER MODEL 5134 receive FDA 510(k) clearance?

EKG TRANSMITTER MODEL 5134 received FDA 510(k) clearance on 1985-03-01, under 510(k) number K842051.

Who is the listed applicant for EKG TRANSMITTER MODEL 5134?

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

What is the FDA product code for EKG TRANSMITTER MODEL 5134?

The FDA product code for EKG TRANSMITTER MODEL 5134 is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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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