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FDA 510(k)

ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH

K-Number: K902738 · 1990-09-04

ApplicantLabeltape Meditect, Inc.
Decision Date1990-09-04
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH 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 1990-09-04 under 510(k) number K902738. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH?

ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH is a medical device that received FDA 510(k) clearance on 1990-09-04. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K902738.

When did ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH receive FDA 510(k) clearance?

ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH received FDA 510(k) clearance on 1990-09-04, under 510(k) number K902738.

Who is the listed applicant for ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH?

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 ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH?

The FDA product code for ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH is DRX.

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Other records listing Labeltape Meditect, Inc. 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.

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Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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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