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FDA 510(k)

BABE-EASE NEONATAL CLOTH ECG ELECTRODE

K-Number: K896844 · 1990-02-12

ApplicantLabeltape Meditect, Inc.
Decision Date1990-02-12
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BABE-EASE NEONATAL CLOTH ECG ELECTRODE 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 1990-02-12 under 510(k) number K896844. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABE-EASE NEONATAL CLOTH ECG ELECTRODE?

BABE-EASE NEONATAL CLOTH ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1990-02-12. The listed applicant is Labeltape Meditect, Inc.. The 510(k) number is K896844.

When did BABE-EASE NEONATAL CLOTH ECG ELECTRODE receive FDA 510(k) clearance?

BABE-EASE NEONATAL CLOTH ECG ELECTRODE received FDA 510(k) clearance on 1990-02-12, under 510(k) number K896844.

Who is the listed applicant for BABE-EASE NEONATAL CLOTH ECG ELECTRODE?

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 BABE-EASE NEONATAL CLOTH ECG ELECTRODE?

The FDA product code for BABE-EASE NEONATAL CLOTH ECG ELECTRODE is GXY.

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Related Devices (Code: GXY)

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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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