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FDA 510(k)

BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE

K-Number: K883762 · 1988-09-27

ApplicantBard Electro Medical Systems, Inc.
Decision Date1988-09-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Bard Electro Medical Systems, Inc.. It received FDA 510(k) clearance on 1988-09-27 under 510(k) number K883762. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE?

BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE is a medical device that received FDA 510(k) clearance on 1988-09-27. The listed applicant is Bard Electro Medical Systems, Inc.. The 510(k) number is K883762.

When did BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE receive FDA 510(k) clearance?

BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE received FDA 510(k) clearance on 1988-09-27, under 510(k) number K883762.

Who is the listed applicant for BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE?

The FDA 510(k) record lists Bard Electro Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE?

The FDA product code for BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE is GEI.

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Official Source

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