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FDA 510(k)

MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM

K-Number: K931148 · 1993-06-09

ApplicantEsa, Inc.
Decision Date1993-06-09
Product CodeCHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Esa, Inc.. It received FDA 510(k) clearance on 1993-06-09 under 510(k) number K931148. The device is classified under product code CHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM?

MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM is a medical device that received FDA 510(k) clearance on 1993-06-09. The listed applicant is Esa, Inc.. The 510(k) number is K931148.

When did MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM receive FDA 510(k) clearance?

MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM received FDA 510(k) clearance on 1993-06-09, under 510(k) number K931148.

Who is the listed applicant for MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM?

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

What is the FDA product code for MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM?

The FDA product code for MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM is CHQ.

Related Clinical Trials

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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Other records listing Esa, 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.

K032199ESA PLASMA FREE METANEPHRINE ANALYSIS KITK971640LEADCARE BLOOD LEAD TESTING SYSTEMK963938MODEL 5500 CEASK934977MODEL 5500 CEASK903231COULOCHEM IIK864729NEUROCHEMICAL ANALYZER

View all 7 devices →

Related Devices (Code: CHQ)

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.

K051969TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIAIbl GmbHK032199ESA PLASMA FREE METANEPHRINE ANALYSIS KITEsa, Inc.K972167PLASMA CATECHOLAMINE KITBioanalytical Systems, Inc.K963938MODEL 5500 CEASEsa, Inc.K952919URINARY METANEPHRINE KITBioanalytical Systems, Inc.K943099URINARY CATECHOLAMINE KITBioanalytical Systems, Inc.

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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