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FDA 510(k)

ECG & ULTRASOUND GELS, CREAMS & LOTION

K-Number: K803151 · 1980-12-30

ApplicantAbco Dealers, Inc.
Decision Date1980-12-30
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ECG & ULTRASOUND GELS, CREAMS & LOTION is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1980-12-30 under 510(k) number K803151. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG & ULTRASOUND GELS, CREAMS & LOTION?

ECG & ULTRASOUND GELS, CREAMS & LOTION is a medical device that received FDA 510(k) clearance on 1980-12-30. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K803151.

When did ECG & ULTRASOUND GELS, CREAMS & LOTION receive FDA 510(k) clearance?

ECG & ULTRASOUND GELS, CREAMS & LOTION received FDA 510(k) clearance on 1980-12-30, under 510(k) number K803151.

Who is the listed applicant for ECG & ULTRASOUND GELS, CREAMS & LOTION?

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

What is the FDA product code for ECG & ULTRASOUND GELS, CREAMS & LOTION?

The FDA product code for ECG & ULTRASOUND GELS, CREAMS & LOTION is GYB.

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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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