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FDA 510(k)

POTASSIUM AND SODIUM ELECTROLYTE ANALYZER

K-Number: K890792 · 1989-05-03

ApplicantIonetics, Inc.
Decision Date1989-05-03
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POTASSIUM AND SODIUM ELECTROLYTE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Ionetics, Inc.. It received FDA 510(k) clearance on 1989-05-03 under 510(k) number K890792. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POTASSIUM AND SODIUM ELECTROLYTE ANALYZER?

POTASSIUM AND SODIUM ELECTROLYTE ANALYZER is a medical device that received FDA 510(k) clearance on 1989-05-03. The listed applicant is Ionetics, Inc.. The 510(k) number is K890792.

When did POTASSIUM AND SODIUM ELECTROLYTE ANALYZER receive FDA 510(k) clearance?

POTASSIUM AND SODIUM ELECTROLYTE ANALYZER received FDA 510(k) clearance on 1989-05-03, under 510(k) number K890792.

Who is the listed applicant for POTASSIUM AND SODIUM ELECTROLYTE ANALYZER?

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

What is the FDA product code for POTASSIUM AND SODIUM ELECTROLYTE ANALYZER?

The FDA product code for POTASSIUM AND SODIUM ELECTROLYTE ANALYZER is CEM.

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Other records listing Ionetics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K932179MODEL 400/450 ELECTROLYTE ANALYZERK895397CALCIUM AND PH ELECTROLYTE ANALYZERK863907MODIFIED SODIUM ELECTRODEK851808ELECTROLYTE ANALYZERK830130MINIATURE ION SELECTIVE ELECTRODESK802856MINIATURE ION SELECTIVE ELECTRODES

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Related Devices (Code: CEM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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