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FDA 510(k)

BABY MAC ELECTROCARDIOGRAPH ELECTRODE

K-Number: K895834 · 1989-11-03

ApplicantMarquette Electronics, Inc.
Decision Date1989-11-03
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BABY MAC ELECTROCARDIOGRAPH ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Electronics, Inc.. It received FDA 510(k) clearance on 1989-11-03 under 510(k) number K895834. 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 BABY MAC ELECTROCARDIOGRAPH ELECTRODE?

BABY MAC ELECTROCARDIOGRAPH ELECTRODE is a medical device that received FDA 510(k) clearance on 1989-11-03. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K895834.

When did BABY MAC ELECTROCARDIOGRAPH ELECTRODE receive FDA 510(k) clearance?

BABY MAC ELECTROCARDIOGRAPH ELECTRODE received FDA 510(k) clearance on 1989-11-03, under 510(k) number K895834.

Who is the listed applicant for BABY MAC ELECTROCARDIOGRAPH ELECTRODE?

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

What is the FDA product code for BABY MAC ELECTROCARDIOGRAPH ELECTRODE?

The FDA product code for BABY MAC ELECTROCARDIOGRAPH ELECTRODE is DRX.

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Other records listing Marquette Electronics, Inc. as applicant

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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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