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FDA 510(k)

STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)

K-Number: K872869 · 1987-11-04

ApplicantLabeltape Meditect, Inc.
Decision Date1987-11-04
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE) is the device name listed in this FDA 510(k) record. The listed applicant is Labeltape Meditect, Inc.. It received FDA 510(k) clearance on 1987-11-04 under 510(k) number K872869. 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 STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)?

STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE) is a medical device that received FDA 510(k) clearance on 1987-11-04. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K872869.

When did STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE) receive FDA 510(k) clearance?

STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE) received FDA 510(k) clearance on 1987-11-04, under 510(k) number K872869.

Who is the listed applicant for STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)?

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

What is the FDA product code for STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)?

The FDA product code for STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE) is DXH. This falls under the Hematology category.

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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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