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FDA 510(k)

MODEL 5500 CEAS

K-Number: K963938 · 1996-12-26

ApplicantEsa, Inc.
Decision Date1996-12-26
Product CodeCHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODEL 5500 CEAS is the device name listed in this FDA 510(k) record. The listed applicant is Esa, Inc.. It received FDA 510(k) clearance on 1996-12-26 under 510(k) number K963938. 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 CEAS?

MODEL 5500 CEAS is a medical device that received FDA 510(k) clearance on 1996-12-26. The listed applicant is Esa, Inc.. The 510(k) number is K963938.

When did MODEL 5500 CEAS receive FDA 510(k) clearance?

MODEL 5500 CEAS received FDA 510(k) clearance on 1996-12-26, under 510(k) number K963938.

Who is the listed applicant for MODEL 5500 CEAS?

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 CEAS?

The FDA product code for MODEL 5500 CEAS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK934977MODEL 5500 CEASK931148MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEMK903231COULOCHEM 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.K952919URINARY METANEPHRINE KITBioanalytical Systems, Inc.K943099URINARY CATECHOLAMINE KITBioanalytical Systems, Inc.K931148MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEMEsa, 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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