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FDA 510(k)

ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE

K-Number: K020003 · 2002-11-07

ApplicantBio Protech, Inc.
Decision Date2002-11-07
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Bio Protech, Inc.. It received FDA 510(k) clearance on 2002-11-07 under 510(k) number K020003. 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 ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE?

ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE is a medical device that received FDA 510(k) clearance on 2002-11-07. The listed applicant is Bio Protech, Inc.. The 510(k) number is K020003.

When did ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE receive FDA 510(k) clearance?

ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE received FDA 510(k) clearance on 2002-11-07, under 510(k) number K020003.

Who is the listed applicant for ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE?

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

What is the FDA product code for ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE?

The FDA product code for ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE is DRX.

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Related Devices (Code: DRX)

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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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