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FDA 510(k)

CCA-100 (MODIFIED)

K-Number: K963681 · 1996-10-08

ApplicantBenson Medical Instruments Co.
Decision Date1996-10-08
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CCA-100 (MODIFIED) is the device name listed in this FDA 510(k) record. The listed applicant is Benson Medical Instruments Co.. It received FDA 510(k) clearance on 1996-10-08 under 510(k) number K963681. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CCA-100 (MODIFIED)?

CCA-100 (MODIFIED) is a medical device that received FDA 510(k) clearance on 1996-10-08. The listed applicant is Benson Medical Instruments Co.. The 510(k) number is K963681.

When did CCA-100 (MODIFIED) receive FDA 510(k) clearance?

CCA-100 (MODIFIED) received FDA 510(k) clearance on 1996-10-08, under 510(k) number K963681.

Who is the listed applicant for CCA-100 (MODIFIED)?

The FDA 510(k) record lists Benson Medical Instruments Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CCA-100 (MODIFIED)?

The FDA product code for CCA-100 (MODIFIED) is EWO.

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 Benson Medical Instruments Co. 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.

K123896CCS-200 SPIROMETERK982441CCA-220K981439CCA-200K924652BENSON CCA100

Related Devices (Code: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, 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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