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FDA 510(k)

ION SELECTIVE ELECTRODE

K-Number: K841076 · 1984-05-07

ApplicantCooper Biomedical, Inc.
Decision Date1984-05-07
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ION SELECTIVE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Biomedical, Inc.. It received FDA 510(k) clearance on 1984-05-07 under 510(k) number K841076. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ION SELECTIVE ELECTRODE?

ION SELECTIVE ELECTRODE is a medical device that received FDA 510(k) clearance on 1984-05-07. The listed applicant is Cooper Biomedical, Inc.. The 510(k) number is K841076.

When did ION SELECTIVE ELECTRODE receive FDA 510(k) clearance?

ION SELECTIVE ELECTRODE received FDA 510(k) clearance on 1984-05-07, under 510(k) number K841076.

Who is the listed applicant for ION SELECTIVE ELECTRODE?

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

What is the FDA product code for ION SELECTIVE ELECTRODE?

The FDA product code for ION SELECTIVE ELECTRODE is JJE.

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Related Devices (Code: JJE)

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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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